[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iia-rectal-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iia-rectal-cancer-ajcc-v8":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,70,95,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100576092","phase-2-folfox-botensilimab-and-balstilimab-for-the-treatment-of-localized-rectal-cancer-before-surgery-100576092",false,"NCT06780787","FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery","Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Histologically confirmed adenocarcinoma of the rectum\n* Rectal involvement defined as involvement of the rectum within 12 cm proximal from anal verge\n* Radial margin of at least 3mm from the mesorectal fascia, with no threatened circumferential tumor margin based on MRI. No more than 4 lymph nodes (LN) with short axis \\> 1 cm\n* T3N0, or TxN1 or TxN2 clinical stage based on MRI staging\n* No evidence of distant metastatic disease based on imaging studies including CT chest and CT or MRI of abdomen and pelvis\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Without bone marrow involvement: Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine \\\u003C 1.5 x ULN or clearance of ≥ 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test\n\n  * 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\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* Any treatment for rectal cancer prior to enrollment that includes (but not limited to) chemotherapy, radiation, and\u002For biological therapy\n* Any prior immunotherapy\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* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement or biopsies\n* Concurrent malignancy other than the diagnosis of rectal cancer, with the exception of curatively resected non-melanoma skin cancer, cervical cancer in situ, prostate cancer Gleason 6 or below that is localized to the prostate, or any other curatively resected cancer from which the patient remains in remission for at least 2 years without treatment\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation\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 of acute thrombotic venous events in the last 30 days before enrollment. If within 30 days, the patient should be on anticoagulants and without symptoms\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study\n* History or current evidence of any condition, co-morbidity, therapy, any active infections (requiring antibiotics), or laboratory abnormality 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* Known previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe\u002Fcritical illness prior to cycle 1 day 1 (C1D1)\n* Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required\n* Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV deoxyribonucleic acid (DNA) for at least 6 months prior to study entry 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 provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required\n* Grade 2 or above neuropathy at the time of enrollment\n* Dependence on total parenteral nutrition or intravenous hydration\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":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, 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. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.",[26,27,28],"Rectal Adenocarcinoma","Stage IIA Rectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2025-05-20",{"date":37,"type":20},"2027-11-05",{"name":39,"class":40},"City of Hope Medical Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"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":50,"type":20},120,[52],"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.",[26,55,27,56,57,28,58,59,60],"Stage II 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":63,"type":33},"2026-05-20",{"date":65,"type":33},"2024-03-13",{"date":67,"type":20},"2026-10-31",{"name":69,"class":40},"M.D. Anderson Cancer Center",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":41},"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":78,"type":20},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.",[26,82,55,27,56,57,28,58,59,60,83,84,85,86],"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":89,"type":33},"2026-04-06",{"date":91,"type":33},"2014-05-16",{"date":93,"type":20},"2030-05-31",{"name":69,"class":40},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":41},"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":103,"type":20},25,[105],"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.",[108,26,55,27,56,57,28,58,59,60],"Locally Advanced Rectal Carcinoma","2026-03-25",{"date":111,"type":33},"2026-03-30",{"date":113,"type":33},"2021-02-11",{"date":115,"type":20},"2027-10-15",{"name":117,"class":40},"Jonsson Comprehensive Cancer Center",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"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":125,"type":20},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.",[26,55,27,56,57,28,58,59,60],"2025-09-24",{"date":130,"type":33},"2025-09-25",{"date":132,"type":33},"2021-09-03",{"date":134,"type":20},"2026-09-03",{"name":136,"class":40},"OHSU Knight Cancer Institute",2]