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.
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
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
CPI-613 and Fluorouracil in Treating Patients with Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
This pilot phase I trial studies the side effects and best dose of 6,8-Bis(benzylthio)octanoic acid (CPI-613) when given together with fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by turning off their mitochondria (small structures in a cell that are found in the cytoplasm [fluid that surrounds the cell nucleus]). Mitochondria are used by tumor cells to produce energy and are the building blocks needed to make more tumor cells. By shutting off these mitochondria, CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and grow in the body. Drugs used in chemotherapy, such as 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 CPI-613 with fluorouracil may kill more tumor cells.
Location: Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina
Dendritic Cell Vaccine, Recombinant Interferon Alfa, Rintatolimod, and Celecoxib After Surgery in Treating Patients with Peritoneal Surface Cancers
This phase I / II trial studies the side effects and best dose of recombinant interferon alfa when given together with a dendritic cell vaccine, rintatolimod, and celecoxib after surgery in treating patients with cancer on the surface of the peritoneum that spread from the appendix, colon, or rectum. Vaccines made from a person's dendritic cells (a type of white blood cells) mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Recombinant interferon alfa may improve the body's natural response to infections and other diseases. It may also interfere with the division of tumor cells and growth of tumors. Celecoxib and rintatolimod may help stimulate the immune system. Giving a dendritic cell vaccine, recombinant interferon alfa, celecoxib, and rintatolimod together may help stimulate the immune system to kill more tumor cells.
Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania
Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin C Followed by Standard Chemotherapy in Treating Patients with Peritoneal Carcinomatosis
This phase II trial studies how well cytoreductive surgery and hyperthermic intraperitoneal mitomycin C followed by standard chemotherapy works in treating patients with peritoneal carcinomatosis. Cytoreductive surgery helps to reduce the number of cancer cells prior to treatment. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Drugs used in chemotherapy, such as mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing mitomycin C directly into the abdomen may kill more tumor cells while reducing side effects. Giving cytoreductive surgery with hyperthermic intraperitoneal mitomycin C may kill more tumor cells.
Location: Montefiore Medical Center-Weiler Hospital, Bronx, New York
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 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
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
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 M3814 in Combination With Capecitabine and Radiotherapy in Rectal Cancer
The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR) / Clinical Complete Response (cCR) when administered in combination with capecitabine and RT versus placebo, capecitabine, and RT in Phase II.
Location: 4 locations
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don't belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe and effective.
Location: Location information is not yet available.
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
Nilotinib and Cetuximab in Treating Patients With Solid Tumors That Can Be Treated With Cetuximab
This phase I trial studies the side effects and the best dose of nilotinib when given together with cetuximab in treating patients with solid tumors that can be treated with cetuximab. Nilotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving nilotinib and cetuximab may be an effective treatment for solid tumors.
Location: MedStar Georgetown University Hospital, Washington, District of Columbia
TAS-102 and Radiation Therapy in Treating Patients with Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of trifluridine and tipiracil hydrochloride (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.
Location: 2 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