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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003862 |
Purpose
RATIONALE: Drugs used in chemotherapy 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. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach |
| Study Start Date: | November 1999 |
OBJECTIVES:
OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.
Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.
Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the stomach
Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 55 Study Locations| Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000067026, RTOG-9904, RTOG-DEV-1046 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003862 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
|
Antimetabolites Vitamin B Complex Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Leucovorin Trace Elements Antimitotic Agents Folinic Acid Immunosuppressive Agents Calcium, Dietary Digestive System Diseases |
Stomach Diseases Cisplatin Paclitaxel Vitamins Stomach Neoplasms Fluorouracil Tubulin Modulators Gastrointestinal Neoplasms Micronutrients Stomach Cancer Adenocarcinoma Antineoplastic Agents, Phytogenic |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Leucovorin Stomach Diseases Neoplasms by Site Stomach Neoplasms Therapeutic Uses Vitamins Micronutrients |
Digestive System Neoplasms Vitamin B Complex Growth Substances Mitosis Modulators Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Paclitaxel Fluorouracil Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |