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 26-44 of 44

  • 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: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer

    This study is being done to look at the safety and response to the investigational drug durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment will be completed just before the course of durvalumab is initiated. In order to learn more about certain characteristics of rectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, a tissue sample from tumors removed during surgery, fresh tumor samples from an area where the cancer has recurred, and blood samples.
    Location: 2 locations

  • Capecitabine, Lenvatinib Mesylate, and External Beam Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer before Surgery

    This phase I trial studies the side effects and best dose of capecitabine when given together with lenvatinib mesylate and external beam radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Drugs used in chemotherapy, such as 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. Lenvatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving capecitabine, lenvatinib mesylate, and external beam radiation therapy may kill more tumor cells.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Niclosamide in Treating Patients with Colon Cancer That Can Be Removed by Surgery

    This phase I trial studies the side effects of niclosamide in treating patients with colon cancer that can be removed by surgery. Niclosamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Duke University Medical Center, Durham, North Carolina

  • D Vitamin in Treating Participants with Stage III Colon Cancer or Stage II / III Rectal Cancer

    This pilot trial studies how well D vitamin works in treating participants with stage III colon cancer or stage II / III rectal cancer. D vitamin may raise serum vitamin D levels and impact survival of colon and rectal cancer patients.
    Location: Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon

  • TAS-102 and Yttrium-90 Microsphere Radioembolization in Treating Patients with Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

    This phase I trial studies the side effect and best dose of trifluridine / tipiracil hydrochloride combination agent TAS-102 (TAS-102) and to see how well it works when given together with Yttrium-90 microsphere radioembolization in treating patients with colorectal cancer that has spread to other places in the body and cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine / tipiracil hydrochloride combination agent TAS-102, 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. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Chemoembolization may cause fewer side effects in treating patients with colorectal cancer. Giving trifluridine / tipiracil hydrochloride combination agent TAS-102 and Yttrium-90 microsphere radioembolization may work better in treating patients with colorectal cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • DNA Methyltransferase Inhibitor SGI-110, Donor GVAX and Cyclophosphamide in Treating Patients with Metastatic Colorectal Cancer

    This randomized pilot phase I trial studies deoxyribonucleic acid (DNA) methyltransferase inhibitor SGI-110, donor autologous granulocyte macrophage colony-stimulating factor (GM-CSF)-secreting lethally irradiated colorectal cancer cell vaccine (GVAX), and cyclophosphamide in treating patients with colorectal cancer that has spread to other places in the body. GVAX vaccine consists of two parts that are mixed together. One part of the vaccine is made from other patient's colon cancer cells and the other part is made from leukemia cells. The leukemia cells have been genetically changed, meaning that a certain gene was put into the DNA of those cells. A gene is a piece of DNA that carries a message that tells cells to make something, such as GM-CSF, a protein that has been shown to stimulate the immune response. DNA methyltransferase inhibitor SGI-110 may block abnormal cells or tumor cells from growing by blocking some of the enzymes needed for tumor growth. Drugs used in chemotherapy, such as cyclophosphamide, 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. Cyclophosphamide may also help the immune system respond better to treatment with the vaccine. Giving DNA methyltransferase inhibitor SGI-110 and / or cyclophosphamide together with GVAX may be a safe and successful treatment for patients with metastatic colorectal cancer.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

    The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.
    Location: UC Irvine Health / Chao Family Comprehensive Cancer Center, Orange, California

  • Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)

    This study will evaluate the safety, tolerability and preliminary efficacy of MK-8353 when administered in combination with pembrolizumab (MK-3475). There are two parts in this study: Part 1 will be dose escalation and confirmation, and Part 2 will be a cohort expansion. In Part 1, the recommended phase II dose (RP2D) of MK-8353 in combination with a fixed dose of pembrolizumab in participants with advanced malignancies will be identified and confirmed. Participants will be initially enrolled to receive MK-8353 at 350 mg twice a day (BID) in combination with pembrolizumab at a fixed dose of 200 mg on Day 1 of each 3-week cycle (Q3W) for up to 24 months of treatment. In Part 2, participants with advanced colorectal cancer (CRC) that is microsatellite stable (i.e., non-microsatellite instability-high / deficient mismatch repair [non-MSI-H / dMMR]) who received at least one and up to five prior lines of therapy will be enrolled at the RP2D in the expansion cohort to further evaluate safety and efficacy. The protocol has been amended to lower the starting doses of MK-8353 in combination with pembrolizumab. In addition, 3 arms have been added: one in which MK-8353 will be administered continuously once a day (QD) in combination with pembrolizumab, one optional arm in which MK-8353 will be administered 1 week on / 1 week off QD in combination with pembrolizumab and one optional arm in which participants undergo a MK-8353 QD run-in period prior to starting combination therapy with pembrolizumab.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and 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: 634 locations

  • Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

    We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally. STUDY OBJECTIVE To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS) Primary endpoints - DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups); - DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer). Secondary endpoints - Overall survival (OS) over 5 years - DFS and OS in - Chinese, Malay, Indian and other ethnic groups - Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually - Compliant versus non-compliant subjects - PIK3CA mutated tumors (where samples are available)
    Location: See Clinical Trials.gov

  • Study of Romiplostim for Chemo-induced Thrombocytopenia in Adults Subjects With Gastrointestinal or Colorectal Cancer

    Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal or Colorectal Cancer
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Encorafenib, Binimetinib, and Nivolumab in Treating Patients with Microsatellite Stable BRAFV600E Metastatic Colorectal Cancer

    This phase I / II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Panitumumab, Regorafenib, or TAS-102, in Treating Patients with Metastatic and / or Unresectable RAS Wild-Type Colorectal Cancer

    This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body, and / or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.
    Location: 6 locations

  • Radiation Therapy and Chemotherapy in Treating Patients with Stage I-IIIB Rectal Cancer

    This phase II trial studies how well patients with stage I-IIIB rectal cancer respond to a short course of radiation therapy followed by chemotherapy. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, 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. A combination of radiation therapy and chemotherapy may prevent patients from needing surgery, could delay their need for surgery, or may mean that they need less drastic surgery and could potentially avoid a permanent ostomy (a surgically created connection between the intestine and the abdominal wall that allows for elimination of stool).
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Active Surveillance and Chemotherapy before Surgery in Treating Participants with Stage II-III Rectal Cancer

    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.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Epacadostat with Standard Chemoradiation Therapy before Surgery in Treating Patients with Locally Advanced Rectal Cancer

    This phase I trial studies the side effects and best dose of epacadostat when given together with standard cheotherapy and radiation therapy (chemoradiation) before surgery in treating patients with rectal cancer that has spread to nearby tissues and lymph nodes. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving epacadostat in addition to standard chemoradiation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • 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 (advanced / metastatic) and cannot be removed by surgery. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Monoclonal antibodies, such as pertuzumab and cetuximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as 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: 641 locations

  • Universal Donor Natural Killer Cells and ALT-803 in Treating Patients with Relapsed or Refractory Blood Cancer, Colon / Rectal Cancer, or Soft Tissue Sarcoma

    This phase I trial studies the best dose of universal donor natural killer cells when given together with superagonist interleukin-15:interleukin-15 receptor alphaSu / Fc fusion complex ALT-803 (ALT-803) in treating patients with blood cancer, colon / rectal cancer, or soft tissue sarcoma that has come back after a period of improvement or does not respond to treatment. Natural killer cells are a type of white blood cell that may kill tumor cells. ALT-803 may enhance natural killer cell survival and enable them to increase in number after infusion. Giving natural killer cells and ALT-803 may kill more tumor cells.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio