Clinical Trials Using Fluorouracil

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Fluorouracil. 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 93
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  • 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: 974 locations

  • FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients with Metastatic Pancreatic Cancer

    This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.
    Location: 788 locations

  • S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation before Surgery in Treating Patients with Pancreatic Cancer That Can Be Removed by Surgery

    This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, 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. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.
    Location: 734 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

  • Combination Chemotherapy with or without Atezolizumab in Treating Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

    This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination 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. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
    Location: 395 locations

  • Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery

    This randomized phase II-R / III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, 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. Erlotinib hydrochloride 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 chemotherapy together with or without erlotinib hydrochloride and / or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and / or radiation therapy in treating pancreatic cancer.
    Location: 660 locations

  • Risk-Based Therapy in Treating Younger Patients with Newly Diagnosed Liver Cancer

    This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
    Location: 183 locations

  • Individualized Treatment in Treating Patients with Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

    There are two study questions we are asking in this randomized phase II / III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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 giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
    Location: 123 locations

  • Combination Chemotherapy with or without Hypofractionated Radiation Therapy before Surgery in Treating Patients with Pancreatic Cancer

    This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, 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. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.
    Location: 101 locations

  • Radiation Therapy and Cisplatin or Mitomycin and Fluorouracil in Treating Patients with Non-Muscle Invasive Stage I Bladder Cancer

    This phase II trial studies how well radiation therapy when given together with cisplatin or mitomycin and fluorouracil prevents cancer from returning after surgery in patients with bladder cancer that has not invaded the bladder muscle but has not responded to standard treatment. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, mitomycin, 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 these chemotherapy drugs may make tumor cells more sensitive to radiation therapy.
    Location: 65 locations

  • Topical or Ablative Treatment in Preventing Anal Cancer in Patients with HIV and Anal High-Grade Squamous Intraepithelial Lesions

    This randomized phase III trial compares topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer.
    Location: 25 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

  • Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177 / KEYNOTE-177)

    In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) compared to current SOC chemotherapy.
    Location: 25 locations

  • A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

    This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
    Location: 16 locations

  • Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan / Cetuximab or Infusional 5-Fluorouracil (5-FU) / Folinic Acid (FA) / Irinotecan (FOLFIRI) / Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

    This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan / cetuximab or FOLFIRI / cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.
    Location: 12 locations

  • Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Study Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

    The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer
    Location: 15 locations

  • Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

    The purpose of this study is to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
    Location: 9 locations

  • Docetaxel, Cisplatin, and Fluorouracil in Treating Patients with Gastric or Gastroesophageal Junction Cancer That is Metastatic or Cannot Be Removed by Surgery

    This randomized phase II trial studies how well docetaxel, cisplatin, and fluorouracil work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, 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.
    Location: 10 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

  • Combination Chemotherapy with or without Ramucirumab in Treating Patients with Metastatic or Recurrent Pancreatic Cancer

    This randomized phase II trial studies how well combination chemotherapy with or without ramucirumab works in treating patients with pancreatic cancer that has spread from the primary site to other places in the body or come back after a period of time during which the cancer could not be detected. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, 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. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if combination chemotherapy is more effective with or without ramucirumab in treating patients with pancreatic cancer.
    Location: 8 locations

  • Imiquimod, Fluorouracil, or Observation in Treating Patients With High-Grade Anal Squamous Skin Lesions Who Are HIV-Positive

    This randomized phase III trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating patients with high-grade anal squamous skin lesions who are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. 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. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions.
    Location: 8 locations

  • Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach / Esophagus Junction Cancer

    The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.
    Location: 9 locations

  • Panitumumab and Combination Chemotherapy with or without Hepatic Arterial Infusion in Treating Patients with Wild Type RAS Colorectal Cancer Metastatic in the Liver That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well panitumumab and combination chemotherapy with or without hepatic arterial infusion work in treating patients with wild type RAS colorectal cancer that has spread to the liver and cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as floxuridine, dexamethasone, leucovorin calcium, fluorouracil, and irinotecan, 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. Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Giving panitumumab and combination chemotherapy with or without hepatic arterial infusion may kill more tumor cells and allow patients to have liver tumors removed surgically.
    Location: 6 locations

  • Pembrolizumab, Trastuzumab, Fluorouracil, and Combination Chemotherapy as First Line Therapy in Treating Patients with HER2-Positive Stage IV Esophagogastric Cancer

    This phase II trial studies how well pembrolizumab works when given together with trastuzumab and combination chemotherapy as first line therapy in treating patients with HER2-positive stage IV esophagogastric cancer. Monoclonal antibodies, such as pembrolizumab and trastuzumab, may block tumor growth in different ways by targeting certain cells. Drugs used in combination chemotherapy, such as capecitabine, cisplatin, oxaliplatin, 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 pembrolizumab with trastuzumab and combination chemotherapy may work better as first line therapy in treating patients with esophagogastric cancer.
    Location: 7 locations

  • Ramucirumab, Trastuzumab, Capecitabine, and Cisplatin in Treating Patients with Stage IV HER2-Positive Gastroesophageal Junction or Gastric Cancer

    This phase II trial studies how well ramucirumab, trastuzumab, capecitabine, and cisplatin work in treating patients with stage IV human epidermal growth factor receptor (HER)2-positive gastroesophageal junction or gastric cancer. Ramucirumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine and cisplatin, 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 ramucirumab, trastuzumab, capecitabine, and cisplatin may kill more tumor cells in HER2-positive gastroesophageal junction or gastric cancer.
    Location: 6 locations


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