Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
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| ClinicalTrials.gov Identifier: NCT00003862 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : October 19, 2020
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer | Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Masking: | None (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 |
| Actual Primary Completion Date : | November 2004 |
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| Ages Eligible for Study: | 0 Years to 120 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically proven adenocarcinoma of the stomach
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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
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- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003862
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| Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003862 |
| Other Study ID Numbers: |
RTOG-9904 CDR0000067026 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | October 19, 2020 |
| Last Verified: | September 2003 |
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stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Leucovorin Paclitaxel Fluorouracil Calcium Levoleucovorin Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |