Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach |
| Study Start Date: | November 1999 |
OBJECTIVES:
- Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
- Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
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)
- No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)
- Potentially resectable
- May involve the gastroesophageal junction, but bulk of tumor must be in the stomach
- No distant metastases
- No pleural or pericardial effusion
- No peritoneal disease diagnosed by laparoscopy
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- At least 16 weeks
Hematopoietic:
- Absolute granulocyte count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No hypertension
Neurologic:
- No cerebrovascular disease
- No diabetic neuropathy
- No mental status abnormalities
Other:
- No uncontrolled diabetes
- No infection
- No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to stomach
Surgery:
- No prior surgery to stomach
Contacts and Locations
Show 55 Study Locations| Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003862 History of Changes |
| Other Study ID Numbers: | CDR0000067026, RTOG-9904, RTOG-DEV-1046 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
Additional relevant MeSH terms:
|
Adenocarcinoma Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Cisplatin Fluorouracil Paclitaxel |
Leucovorin Levoleucovorin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on June 18, 2013