Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

Jaffer A. Ajani

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003862
Information obtained from ClinicalTrials.gov on November 20, 2012

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