Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: fluorouracil
* Drug: leucovorin calcium
* Drug: paclitaxel
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy
* Radiation: radiation therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Drug: paclitaxel|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV gastric cancer, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, adenocarcinoma of the stomach