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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00011960 |
RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.
Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.
Condition | Intervention | Phase |
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Esophageal Cancer Gastric Cancer |
Drug: cisplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | David Paul Kelsen, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068464, RTOG-G-0114 |
Study First Received: | March 3, 2001 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00011960 History of Changes |
Health Authority: | United States: Federal Government |
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage I esophageal cancer |
stage II esophageal cancer stage III esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Adjuvants, Immunologic Esophageal Cancer Antimitotic Agents Digestive System Diseases Stomach Diseases Radiation-Sensitizing Agents Cisplatin Paclitaxel |
Esophageal Disorder Fluorouracil Stomach Neoplasms Head and Neck Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Antineoplastic Agents, Phytogenic |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Pharmacologic Actions Neoplasms Digestive System Diseases Neoplasms by Site |
Stomach Diseases Radiation-Sensitizing Agents Cisplatin Paclitaxel Therapeutic Uses Stomach Neoplasms Head and Neck Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic |