Treatment Clinical Trials for Rectal Cancer

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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 46
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  • NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma

    This phase II 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: 1170 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: 973 locations

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

    This randomized phase II trial studies how well veliparib works 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. 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 with combination chemotherapy and radiation therapy may kill more tumor cells and giving it before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: 505 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: 23 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

  • Phase I / II Study of IMMU-132 in Patients With Epithelial Cancers

    The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated patients with advanced epithelial cancer.The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan. This is planned as a multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up to 50 patients (assessable) per other cancer types included in the protocol will be studied at the 10 mg / kg dose.
    Location: 8 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

  • Phase 1 Study of MGD007 in Relapsed / Refractory Metastatic Colorectal Carcinoma

    The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) and schedule of MGD007 administered to patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will also be assessed.
    Location: 5 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

  • Chemotherapy, Radiation Therapy, and Midostaurin in Treating Patients with Locally Advanced Rectal Cancer

    This phase I trial studies the side effects and best dose of midostaurin when given together with 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). 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. Midostaurin 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 and shrink tumors. Giving radiation therapy and chemotherapy together with midostaurin may kill more tumor cells.
    Location: 4 locations

  • Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed / Refractory Cancer Indications

    This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients with relapsed / refractory multiple myeloma (MM), colorectal cancer (CRC), metastatic castration resistant prostate cancer (mCRPC), and higher risk myelodysplastic syndrome (MDS). Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.
    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

  • 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: 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

  • Combination of TATE and PD-1 Inhibitor in Liver Cancer

    This is a single center, open-label phase IIA study that investigates the preliminary efficacy of TATE treatment of liver cancer followed by a PD-1 checkpoint inhibitor (either nivolumab or pembrolizumab). At least two cohorts will be enrolled, one for patients with hepatocellular carcinoma (HCC) and the other with metastatic colorectal cancer (mCRC).
    Location: UC Irvine Health / Chao Family Comprehensive Cancer Center, Orange, California

  • 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: Icahn School of Medicine at Mount Sinai, New York, New York

  • 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

  • Safety and Efficacy of Intra-Arterial Ad-p53 in Liver Metastases of Solid Tumors

    This is a Phase 1 study of the combination of Ad-p53 administered intra-arterially in combination with oral metronomic capecitabine in patients with unresectable, refractory liver metastases of colorectal carcinoma (CRC) and other solid tumors, including primary hepatocellular carcinoma (HCC). This safety study has a standard 3+3 design. The Maximum Tolerated Dose (MTD) will be determined as well as the general safety and preliminary efficacy using RECIST 1.1 and Immune-Related Response Criteria. CEA levels will also be followed.
    Location: M D Anderson Cancer Center, Houston, Texas

  • 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

  • Radiation Therapy with FOLFOX Chemotherapy in Treating Patients with Stage I Rectal Cancer

    This pilot phase I trial studies how well radiation therapy with fluorouracil / leucovorin calcium / oxaliplatin (FOLFOX regimen) works in treating patients with stage I rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, 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 more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • 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-Parnassus, San Francisco, California

  • Carbon C 14 Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy in Patients with Advanced Colorectal Cancer

    This pilot clinical trial studies how well carbon C 14 oxaliplatin microdosing assay works in predicting exposure and sensitivity to oxaliplatin-based chemotherapy in patients with colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as 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. Carbon C 14 is a radioactive form of carbon, exists in nature and in the body at a low level. Microdose carbon C 14 oxaliplatin diagnostic assay may help doctors understand how well patients respond to treatment and develop individualize oxaliplatin dosing in patients with colorectal cancer.
    Location: University of California Davis Comprehensive Cancer Center, Sacramento, California


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