[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iiib-rectal-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iiib-rectal-cancer-ajcc-v8":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,80,105,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100641439","phase-2-neoadjuvant-botensilimab-and-balstilimab-for-the-treatment-of-advanced-resectable-colorectal-cancer-nest3-100641439",false,"NCT07595874","Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3","A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)","NEST3","Inclusion Criteria:\n\n* Documented informed consent of the participant and Legally Authorized Representative (when applicable)\n\n  * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines\n* Agreement to allow the use of tissue from past and future surgery and standard of care biopsies\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed or cytologically confirmed colorectal adenocarcinoma. Patients with high grade dysplasia on histology plus unequivocal endoscopic or radiological evidence of invasive cancer are eligible.\n\nPatients diagnosed with rectal cancer who will be treated like colon cancer with curative-intent surgery first and no radiation are also eligible, including:\n\n* Upper rectum or rectosigmoid considered as non-rectal and not undergoing neoadjuvant treatment\n* The tumor component should not extend to less 12 cm from the anal verge.\n* Any patient with rectal cancer for whom radiotherapy is not advised is included in this protocol (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation)\n\n  * Microsatellite stability by mismatch repair by immunohistochemistry, polymerase chain reaction and\u002For other Clinical Laboratory Improvement Amendments (CLIA) certified next generation sequencing. Only patients with mismatch repair proficient or microsatellite stable (pMMR\u002FMSS) tumors are allowed to enroll in the study\n  * Candidate for and planning a curative resection. Must have surgeon identified\n  * T4, N+ (American Joint Committee on Cancer \\[AJCC\\] TNM staging criteria), or both by central radiographic assessment.\n* Note: Patients with T3N0 stage IIA are excluded. Stage IIB, IIC, IIIA, IIIB, and IIIC are included. Patients with stage IV disease are excluded\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n  * Platelets ≥ 75,000\u002Fmm\\^3\n* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n\n  * Hemoglobin ≥ 8 g\u002FdL\n* NOTE: Red blood cell transfusions are permitted. Patients should not have active clinically significant bleeding requiring regular transfusions. Iron infusions are also allowed\n\n  * Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, in which case the liver function tests must meet the other eligibility in the protocol)\n  * Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n  * Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Creatinine clearance of ≥ 40 mL\u002Fmin per the Cockcroft-Gault formula\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\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 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and\u002For botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and\u002For botensilimab.\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* The following are acceptable birth control methods for this study: Surgical sterilization (tubal ligation or hysterectomy for women, or vasectomy for men), double-barrier methods (i.e. condoms, diaphragm, cervical cap, or sponge, used together with spermicidal gel or foam), intrauterine device (IUD) (i.e. Progestin, Copper), or hormonal contraceptives (birth control patches, implants, pills, rings, or injections)\n\nExclusion Criteria:\n\n* Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and\u002For biological therapy.\n\n  * Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the study as long as no distant metastatic disease\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Prior allogeneic organ transplantation\n* Herbal medications that require a prescription or are anti-cancer\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. Please note: patients with more than 1 colorectal cancer tumor at diagnosis (as long as no stage IV disease) are allowed to participate. Pathologic response to each of the tumors will be examined\n* Active acute colonic obstruction. Patients whose obstruction is relieved by a successful defunctioning stoma are allowed once recovered to a fitness level consistent with the other eligibility criteria\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Prior allergic reaction or hypersensitivity to any of the study drug components\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)\n* History or current evidence of any condition, co-morbidity, therapy, that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n* Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) are eligible. Serological testing for HIV at screening is not required\n* Uncontrolled infection with hepatitis B virus. Patients who are receiving or who have received anti-HBV therapy are eligible. Serological testing for HBV at screening is not required\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible. Serological testing for HCV at screening is not required\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)","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Advanced Colon Adenocarcinoma","Advanced Colorectal Adenocarcinoma","Advanced Rectal Adenocarcinoma","Stage IIB Colon Cancer AJCC v8","Stage IIB Rectal Cancer AJCC v8","Stage IIC Colon Cancer AJCC v8","Stage IIC Rectal Cancer AJCC v8","Stage IIIA Colon Cancer AJCC v8","Stage IIIA Rectal Cancer AJCC v8","Stage IIIB Colon Cancer AJCC v8","Stage IIIB Rectal Cancer AJCC v8","Stage IIIC Colon Cancer AJCC v8","Stage IIIC Rectal Cancer AJCC v8","RECRUITING","2026-06-29",{"date":43,"type":44},"2026-07-01","ACTUAL",{"date":46,"type":21},"2026-12-27",{"date":48,"type":21},"2027-05-27",{"name":50,"class":51},"City of Hope Medical Center","OTHER",11,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"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":61,"type":21},120,[63],"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.",[66,67,68,31,33,69,35,37,39],"Rectal Adenocarcinoma","Stage II Rectal Cancer AJCC v8","Stage IIA Rectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","2026-05-18",{"date":72,"type":44},"2026-05-20",{"date":74,"type":44},"2024-03-13",{"date":76,"type":21},"2026-10-31",{"name":78,"class":51},"M.D. Anderson Cancer Center",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":79},"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":88,"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.",[66,92,67,68,31,33,69,35,37,39,93,94,95,96],"Stage I Rectal Cancer AJCC v8","Stage IV Rectal Cancer AJCC v8","Stage IVA Rectal Cancer AJCC v8","Stage IVB Rectal Cancer AJCC v8","Stage IVC Rectal Cancer AJCC v8","2026-03-31",{"date":99,"type":44},"2026-04-06",{"date":101,"type":44},"2014-05-16",{"date":103,"type":21},"2030-05-31",{"name":78,"class":51},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":79},"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":113,"type":21},25,[115],"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.",[118,66,67,68,31,33,69,35,37,39],"Locally Advanced Rectal Carcinoma","2026-03-25",{"date":121,"type":44},"2026-03-30",{"date":123,"type":44},"2021-02-11",{"date":125,"type":21},"2027-10-15",{"name":127,"class":51},"Jonsson Comprehensive Cancer Center",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"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":135,"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.",[66,67,68,31,33,69,35,37,39],"2025-09-24",{"date":140,"type":44},"2025-09-25",{"date":142,"type":44},"2021-09-03",{"date":144,"type":21},"2026-09-03",{"name":146,"class":51},"OHSU Knight Cancer Institute",2]