Treatment Clinical Trials for Rectal Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for rectal cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 50
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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1193 locations

  • Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

    This randomized phase II / III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes undergoing surgery. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer.
    Location: 900 locations

  • S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients with Locally Advanced or Metastatic HER2 / Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2 / neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, 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 trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.
    Location: 627 locations

  • Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient with Locally Advanced Rectal Cancer

    This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab with combination chemotherapy and radiation therapy may kill more tumor cells, make the tumor smaller, and reduce the amount of normal tissue that needs to be removed.
    Location: 555 locations

  • Chemotherapy before or after Chemoradiation Followed by Surgery or Non-operative Management in Treating Patients with Previously Untreated Stage II-III Rectal Cancer

    This randomized phase II trial studies how well chemotherapy before or after chemoradiation followed by surgery or non-operative management works in treating patients with previously untreated stage II-III rectal cancer. Drugs used in chemotherapy, such as FOLFOX regimen (leucovorin calcium, fluorouracil, oxaliplatin), and CapeOX (oxaliplatin and capecitabine), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving chemotherapy before or after chemoradiation is more effective in treating rectal cancer. Additional chemotherapy may reduce the number of patients that require surgery.
    Location: 20 locations

  • Transanal Total Mesorectal Excision with Laparoscopic Assistance in Treating Patients with Rectal Cancer

    This phase II trial studies how well transanal mesorectal excision with laparoscopic assistance works in treating patients with rectal cancer. Transanal mesorectal excision with laparoscopic assistance is a procedure that combines standard laparoscopy, or multiple small abdominal incisions, with surgery through the anus in order to remove rectal cancer, and it may work better in treating patients with rectal cancer.
    Location: 11 locations

  • Genetic Testing in Determining Irinotecan Hydrochloride Dose in Patients with Metastatic Colorectal Cancer Receiving FOLFIRI and Bevacizumab

    This phase II trial studies how well genetic testing works in determining irinotecan hydrochloride dose in patients with colorectal cancer that has spread to other areas of the body, who are receiving leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) and bevacizumab. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving monoclonal antibody therapy with chemotherapy may kill more tumor cells. Genetic testing may help doctors determine how the body breaks down and removes irinotecan hydrochloride. Using genetic testing to determine the dose of irinotecan hydrochloride may be more effective and safer than standard dosing.
    Location: 9 locations

  • Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients with Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

    This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as trifluridine and tipiracil hydrochloride, 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 trametinib and trifluridine and tipiracil hydrochloride may prevent cancer cells from dividing and work better in treating patients with colon and rectal cancer.
    Location: 8 locations

  • Cabozantinib-S-Malate and Panitumumab in Treating Patients with Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery

    This phase Ib / II trial studies the safety and best dose of cabozantinib-s-malate when given together with panitumumab in treating patients with colorectal cancer that has spread to other parts of the body or cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Panitumumab is a monoclonal antibody that blocks the ability of tumor cells to grow and spread. Giving cabozantinib-s-malate with panitumumab may work better in treating patients with colorectal cancer.
    Location: 8 locations

  • A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine / Oxaliplatin and Bevacizumab

    A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
    Location: 9 locations

  • A Study of RO7198457 (Personalized Cancer Vaccine [PCV]) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

    This is a Phase 1a / 1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).
    Location: 12 locations

  • Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer

    The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.
    Location: 8 locations

  • High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management

    This phase I trial studies the side effects and best dose of high-dose-rate brachytherapy when given together with chemotherapy in treating patients with rectal or anal cancer that has come back or gotten worse and cannot be treated with surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. High-dose-rate (HDR) brachytherapy uses the radioactive material to deliver a high radiation dose in a short period of time to the tumor. It may also send less radiation to nearby healthy tissues and may reduce the risk of side effects. Drugs used in chemotherapy, such as capecitabine and fluorouracil, 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 HDR brachytherapy together with capecitabine or fluorouracil may kill more tumor cells.
    Location: 6 locations

  • Guadecitabine and Irinotecan Hydrochloride or Regorafenib or TAS-102 Alone in Treating Patients with Previously Treated Metastatic Colorectal Cancer

    This partially randomized phase I / II trial studies the side effects and best dose of guadecitabine and to see how well it works when given together with irinotecan hydrochloride or regorafenib or trifluridine / tipiracil hydrochloride combination agent TAS-102 (Tas-102) alone in treating patients with previously treated colorectal cancer that has spread to other parts of the body. Guadecitabine, irinotecan hydrochloride, regorafenib, and TAS-102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Stereotactic Radiosurgery in Treating Patients with Oligo-Recurrent Disease

    This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has come back and has spread to 5 or fewer places in the body (oligometastatic disease). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
    Location: 3 locations

  • Stereotactic Radiosurgery in Treating Patients with Oligometastatic Disease

    This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has spread to 5 or fewer places in the body and involves 3 or fewer organs (oligometastatic disease). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
    Location: 3 locations

  • Preoperative Radiotherapy and E7046 in Rectum Cancer

    This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of the combination in the expansion part at RP2D.
    Location: 2 locations

  • Panitumumab and Combination Chemotherapy in Treating Patients with Metastatic Colorectal Cancer Previously Treated with Combination Chemotherapy and Bevacizumab

    This phase II trial studies how well panitumumab and combination chemotherapy works in treating patients with colorectal cancer that has spread to other places in the body and has previously been treated with combination chemotherapy and bevacizumab. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, 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 panitumumab and combination chemotherapy together may kill more tumor cells.
    Location: 2 locations

  • Gemcitabine Hydrochloride and Docetaxel in Treating Patients with Relapsed or Refractory Colorectal Cancer That Is Metastatic or Cannot Be Removed by Surgery

    This phase II trial studies how well gemcitabine hydrochloride and docetaxel work in treating patients with colorectal cancer that has returned or did not respond to treatment and has spread to other parts of the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, 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 more than one drug (combination chemotherapy) may kill more tumor cells.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Preservation of Organs in Participants with Early Rectal Cancer

    This phase II trial studies preservation of organs in participants with early rectal cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and calcium fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving more than one drug (combination chemotherapy), and giving them after local excision may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
    Location: 2 locations

  • M7824 in Treating Participants with Metastatic or Unresectable Color or Rectal Cancer with Microsatellite Instability

    This phase Ib / II trial studies how well anti-PD-L1 / TGFbetaRII fusion protein M7824 (M7824) works in treating participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery with microsatellite instability. Monoclonal antibodies, such as M7824, may interfere with the ability of tumor cells to grow and spread.
    Location: M D Anderson Cancer Center, Houston, Texas

  • M7824 in Treating Participants with HPV Associated Locally Advanced or Metastatic Cancer

    This phase II trial studies how well M7824 works in treating participants with human papillomavirus (HPV) associated cancer that has spread to nearby tissues or lymph nodes, or that has spread to other parts of the body. Biological therapies, such as M7824, use substances made from living organisms that may target and block a pathway that prevents the immune system from effectively fighting the cancer.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Anti-SEMA4D Monoclonal Antibody VX15 / 2503 with or without Ipilimumab or Nivolumab in Treating Patients with Stage I-III Pancreatic Cancer That Can Be Removed by Surgery or Stage IV Colorectal Cancer with Liver Metastasis That Can Be Removed by Surgery

    This randomized pilot phase I trial studies how well anti-SEMA4D monoclonal antibody VX15 / 2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15 / 2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • Atezolizumab with or without Cobimetinib in Treating Participants with Colorectal Cancer with Liver Metastases before surgery

    This phase II trial studies how well atezolizumab with or without cobimetinib works in treating participants with colorectal cancer that has spread to the liver before surgery. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cobimetinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: Duke University Medical Center, Durham, North Carolina

  • Talimogene Laherparepvec, Capecitabine, and Chemoradiation before Surgery in Treating Patients with Locally Advanced or Metastatic Rectal Cancer

    This phase I trial studies the best dose and side effects of talimogene laherparepvec in combination with capecitabine and chemoradiation before surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue and lymph nodes. Drugs used in immunotherapy, such as talimogene laherparepvec, may stimulate the body's immune system to fight tumor cells. Drugs used in chemotherapy, such as capecitabine, fluorouracil and oxaliplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving talimogene laherparepvec, capecitabine, and chemoradiation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: M D Anderson Cancer Center, Houston, Texas


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