[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ii-rectal-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ii-rectal-cancer-ajcc-v8":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,55,84,110,131,153,176,196],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100603974","family-communications-after-genetic-testing-100603974",false,"NCT07143487","Family Communications After Genetic Testing","Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer","Inclusion Criteria:\n\n* STEP 1 PROBANDS: Age \\>= 18 years\n* STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV\n\n  * Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into\u002Finvolve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary\n  * Patients with more than one primary colon adenocarcinoma are eligible\n* STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer\n* STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers\n* STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible\n* STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes\n* STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis\n* STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish\n* STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members\n\n  \\* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician\n* STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene\n* FDRs: Age \\>= 18 years\n* FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes\n* FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents\n* FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish\n\nExclusion Criteria:\n\n\\-",true,"ALL","18 Years",{"count":20,"type":21},4186,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Colon Adenocarcinoma","Colorectal Adenocarcinoma","Rectal Adenocarcinoma","Stage I Colon Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Rectal Cancer AJCC v8","Stage II Colon Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Rectal Cancer AJCC v8","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","Stage IV Colon Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Rectal Cancer AJCC v8","RECRUITING","2026-07-01",{"date":45,"type":46},"2026-07-02","ACTUAL",{"date":48,"type":46},"2026-04-06",{"date":50,"type":21},"2032-11-05",{"name":52,"class":53},"Alliance for Clinical Trials in Oncology","OTHER",276,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100331390","early-phase-1-active-surveillance-and-chemotherapy-before-surgery-in-treating-participants-with-stage-ii-iii-rectal-cancer-100331390","NCT03594630","Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer","Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of rectal adenocarcinoma\n* Eligible for curative resection of rectal adenocarcinoma\n* Rectal tumor location =\\\u003C 12 cm from the anal verge as determined by endoscopy or magnetic resonance imaging (MRI) (if endoscopy report is not available or deemed inadequate my treating oncologist)\n* Nodal involvement confined to the radiation field\n* Radiologically measurable or clinically evaluable disease as defined in the protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2\n* Clinical Stage: Stage II and III. N2 disease is to be estimated as four or more lymph nodes that are \\>= 10 mm. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon including digital rectal exam (DRE), computed tomography (CT) or positron emission tomography (PET)\u002FCT scan of the chest\u002Fabdomen\u002Fpelvis and a pelvic MRI. If a pelvic MRI is performed, it is acceptable to perform CT of the chest\u002Fabdomen, omitting CT imaging of the pelvis. PET\u002FCT is optional.\n* No known contraindication to standard (fluoropyrimidine-based) pelvic chemoradiation (e.g. dihydropyrimidine dehydrogenase \\[DPD\\] deficiency)\n* Patient of child-bearing potential is willing to employ adequate contraception during treatment and after treatment, as directed by treating clinical team\n* Willing to provide written informed consent\n* Willing to return to enrolling medical site for all study assessments\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease (IBD)\n* Diagnosis of MSI-H colorectal cancer at time of consent\n* Recurrent rectal cancer\n* Tumor is causing symptomatic bowel obstruction (patients who have diverting ostomy are eligible)\n* Any prior pelvic radiation\n* Other invasive malignancy undergoing active treatment. Patients receiving prior treatment that precludes standard chemoradiation or ability to receive consolidation\u002Fadjuvant chemotherapy will be excluded from survival analyses\n* Patients unwilling or unable to undergo pelvic MRI",{"count":63,"type":21},120,[65],"EARLY_PHASE1","This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.",[29,35,68,69,70,38,71,72,73],"Stage IIA Rectal Cancer AJCC v8","Stage IIB Rectal Cancer AJCC v8","Stage IIC Rectal Cancer AJCC v8","Stage IIIA Rectal Cancer AJCC v8","Stage IIIB Rectal Cancer AJCC v8","Stage IIIC Rectal Cancer AJCC v8","2026-05-18",{"date":76,"type":46},"2026-05-20",{"date":78,"type":46},"2024-03-13",{"date":80,"type":21},"2026-10-31",{"name":82,"class":53},"M.D. Anderson Cancer Center",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100624118","phase-2-zanidatamab-before-surgery-for-the-treatment-of-her2-positive-colon-and-rectal-cancer-in-patients-planned-for-curative-intent-treatment-100624118","NCT07405476","Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment","A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed colon and\u002For rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers\n* Tumors must be HER2+ve (human epidermal growth factor receptor 2 \\[HER2\\] overexpression 3+ immunohistochemistry \\[IHC\\] or 2+ by IHC and positive fluorescence in situ hybridization \\[FISH\\] or HER2 amplification by next generation sequencing)\n* Tumors must have RAS wildtype genotype\n* Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* Platelet count \\> 100,000 cells\u002F ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Hemoglobin \\> 9g\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Absolute neutrophil count \\> 1000 cells\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Alanine aminotransferase (ALT) ≤ 3 × ULN (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN for participants with Gilbert's disease (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Glomerular filtration rate (GFR) \\> 60ml\u002Fmin (based on creatine, and Cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Adequate cardiac function with left ventricular ejection fraction of at least 50% (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy\n* FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n  \\* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n* Participants with stage IV colon and rectal cancer even if curative intent resection is planned\n* HER2 expression that does not meet documented inclusion criteria\n* RAS mutation\n* MSI-H or mismatch repair deficient rectal cancer\n* Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Participants with known myocardial infarction or unstable angina within 6 months prior to expected date of cycle 1 day 1 (C1D1) are also excluded. Previous anticancer therapy-related CHF must have been ≤ grade 1 at the time of occurrence and must have completely resolved\n* Participants receiving any other investigational agents or an investigational device within 28 days of administering the first dose of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study\n* Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":92,"type":21},38,[94],"PHASE2","This phase II trial studies how well giving zanidatamab before surgery (neoadjuvant) works in treating patients with colon and rectal cancer that is human epidermal growth factor receptor 2 positive (HER2+ve) who are planned for curative intent treatment. Zanidatamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).",[97,98,99,30,31,32,33,34,35,36,37,38],"Colon Carcinoma","Colorectal Carcinoma","Rectal Carcinoma","2026-04-16",{"date":102,"type":46},"2026-04-17",{"date":104,"type":46},"2026-04-07",{"date":106,"type":21},"2029-12-18",{"name":108,"class":53},"Emory University",4,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":83},"100573417","designing-a-dyad-based-mhealth-intervention-to-improve-adherence-to-lifestyle-recommendations-in-colorectal-cancer-survivors-and-their-family-caregivers-100573417","NCT06746012","Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers","Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study","Inclusion Criteria:\n\n* PATIENTS INCLUSION:\n* Adults (18 years of age or older)\n* Diagnosis of stage I-III colon or rectal cancer\n* Undergone curative-intent complete surgical resection (patients who have received non-operative management for rectal cancer may be eligible)\n* Completed treatment (i.e., neo-adjuvant, adjuvant cytotoxic chemotherapy, radiation, or surgical resection) at least six months prior\n* Own a smartphone with internet access and can receive text messages\n* Able to speak, read, and understand English\n* Self-report ability to independently engage in physical activity determined by the Physical Activity Readiness questionnaire (PAR-Q), and if indicated obtain physician clearance\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 determined via medical chart review\n* Presence of a family caregiver (i.e., informal or formal caregiver) willing support the patient and participate in the study\n* Able to provide informed consent\n* FAMILY CAREGIVER INCLUSION:\n* Any adult that resides in the same household as the patient\n* Willing to participate in all aspects of the intervention and in the assessments required for those in the wait-list control condition if applicable\n* Meets the patient inclusion criteria number 1, 5, 6, and 10\n* SMES INCLUSION:\n* Medical, radiation, and surgical oncologists; advanced practice providers, registered nurses; dietitians; exercise physiologists; physical therapists, patient navigators and champions\u002Fadvocates, and social workers with at least 12 months of experience working with CRC survivors\n\nExclusion Criteria:\n\n* PATIENTS EXCLUSION:\n* People with potential contraindications to exercise based on the PAR-Q, for those we are unable to obtain physician clearance\n* Planned major surgery during the study period\n* Scheduled to receive any form of cancer therapy during study participation\n* Concurrent, actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only)\n* Self-reported history of severe cardiovascular, respiratory, musculoskeletal disease, or joints problems that preclude moderate physical activity (PA)\n* Self-reported history of psychiatric disorders that preclude participation in the study intervention or prevent the patient from giving informed consent\n* Concurrent participation in another weight loss, PA, or dietary intervention clinical trial\n* Currently pregnant or trying to become pregnant during the study period\n* living outside the United States (US) during the study period\n* Currently a prisoner\n* FAMILY CAREGIVER EXCLUSION:\n* The same as the patient exclusion criteria",{"count":118,"type":21},70,[24],"This clinical trial develops and tests a mobile health (mHealth) intervention to improve adherence to lifestyle recommendations in colorectal cancer (CRC) survivors and their family caregivers. The current challenge for cancer survivorship is identifying novel approaches to help adhere to the lifestyle recommendations that have been shown to improve symptom burden, health outcomes, and health-related quality of life (HRQoL). The development of a digital health intervention specifically for CRC survivors and family caregivers may improve adherence to the American Cancer Society Nutrition and Physical Activity Guideline for Cancer Survivors and improve family health.",[30,32,33,35,36,38],"2026-04-05",{"date":124,"type":46},"2026-04-09",{"date":126,"type":46},"2024-05-03",{"date":128,"type":21},"2026-12-31",{"name":130,"class":53},"Ohio State University Comprehensive Cancer Center",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":83},"100217380","evaluation-of-quality-of-life-and-utilities-following-surgical-treatment-of-stage-i-iv-rectal-cancer-100217380","NCT02107105","Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer","Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer","Inclusion Criteria:\n\n* Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment\n* Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English\n\nExclusion Criteria:\n\n* Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer\n* Patient has a concurrent cancer diagnosis at the time of consent\n* Patient has recurrent disease",{"count":139,"type":21},430,"OBSERVATIONAL","This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.",[29,32,35,68,69,70,38,71,72,73,41,143,144,145],"Stage IVA Rectal Cancer AJCC v8","Stage IVB Rectal Cancer AJCC v8","Stage IVC Rectal Cancer AJCC v8","2026-03-31",{"date":48,"type":46},{"date":149,"type":46},"2014-05-16",{"date":151,"type":21},"2030-05-31",{"name":82,"class":53},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":83},"100416471","phase-1-short-course-radiation-therapy-and-combination-chemotherapy-for-the-treatment-of-stage-ii-iii-rectal-cancer-100416471","NCT04703101","Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer","Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX","Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma\n* Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI\n* No evidence of metastatic disease\n* Resectable primary lesion\n* Karnofsky performance status (KPS) \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2\n* Absolute neutrophil count (ANC) \\> 1.5 cell\u002Fmm\\^3\n* Hemoglobin (Hgb) \\> 8.0 gm\u002FdL\n* Platelets (PLT) \\> 150,000\u002Fmm\\^3\n* Total bilirubin \\\u003C or equal to 1.5 x upper limit of normal\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C or equal to three times upper limit of normal\n* If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy\n\nExclusion Criteria:\n\n* Active treatment of a separate malignancy\n* Distant metastatic disease as assessed by staging positron emission tomography (PET)\u002Fcomputed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Pregnant and\u002For breastfeeding\n* Medical\u002Fpsychological contraindication to MRI",{"count":161,"type":21},25,[163],"PHASE1","This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.",[166,29,35,68,69,70,38,71,72,73],"Locally Advanced Rectal Carcinoma","2026-03-25",{"date":169,"type":46},"2026-03-30",{"date":171,"type":46},"2021-02-11",{"date":173,"type":21},"2027-10-15",{"name":175,"class":53},"Jonsson Comprehensive Cancer Center",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100445483","establishing-a-ctdna-biomarker-to-improve-organ-preserving-strategies-in-patients-with-rectal-cancer-100445483","NCT05081024","Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer","Inclusion Criteria:\n\n* Participant must provide written informed consent before any study-specific procedures or interventions are performed\n* Participants aged \\>= 18 years\n* Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:\n\n  * T3N0M0 - T4bN2M0\n\nExclusion Criteria:\n\n* Has radiologic evidence of distant metastases at the time of screening\u002Fenrollment\n* Has received prior treatment for their rectal adenocarcinoma\n* Requires or has received blood transfusion within 1 month of study enrollment",{"count":183,"type":21},50,"This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.",[29,35,68,69,70,38,71,72,73],"2025-09-24",{"date":188,"type":46},"2025-09-25",{"date":190,"type":46},"2021-09-03",{"date":192,"type":21},"2026-09-03",{"name":194,"class":53},"OHSU Knight Cancer Institute",2,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":83},"100580194","phase-1-papaverine-in-combination-with-radiation-therapy-for-the-treatment-of-locally-advanced-rectal-cancer-dinomite-trial-100580194","NCT06834126","Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial","DINOMITE (Decreasing Hypoxia With Mitochondrial Inhibition in Locally Advanced Rectal Cancer): Phase 1 Trial of Papaverine in Combination With Radiation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willingness to participate in all correlative studies: fMRI, and tissue collection of tumor and normal rectum (ribonucleic acid \\[RNA\\]\u002Fdeoxyribonucleic acid \\[DNA\\]\u002Fprotein), blood (plasma\u002Fperipheral blood mononuclear cell \\[PBMC\\]) draws and stool collection\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed rectal adenocarcinoma\n* Patient wants to pursue an organ preservation\u002Fnon-operative management (NOM) approach after completion of total neoadjuvant therapy (TNT)\n* Locally advanced rectal cancer (T3-4 or node+, M0)\n* Tumor is microsatellite stable (MSS) (defined as not microsatellite instability-high \\[MSI-H\\] or mismatch repair deficient \\[dMMR\\])\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (within 30 days of start). NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3 (within 30 days of start). NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL (within 30 days of start). NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 30 days of start)\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (within 30 days of start)\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (within 30 days of start)\n* Creatinine clearance of ≥ 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 30 days of start)\n* For patients with known infections only: seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial (within 28 days of start)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 30 days of start)\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy\n* Prior pelvic irradiation resulting in overlapping fields\n* Use of levodopa in the last 30 days\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Unable to undergo MRI and endoscopic procedures\n* History of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":204,"type":21},36,[163],"This phase I trial studies the side effects and best dose of papaverine (PPV) when given together with radiation therapy (RT) and tests how well it works in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). PPV is an enzyme inhibitor, and it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving PPV with RT may be safe, tolerable, and\u002For effective in treating patients with locally advanced rectal cancer.",[208,35,38],"Locally Advanced Rectal Adenocarcinoma","2025-07-16",{"date":211,"type":46},"2025-07-18",{"date":213,"type":46},"2025-04-07",{"date":215,"type":21},"2028-09-19",{"name":217,"class":53},"City of Hope Medical Center"]