NCT00003862

Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 0 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
DRUG	leucovorin calcium
DRUG	paclitaxel
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 1999-11-01
• Primary completion: 2004-11-01
• First posted: 2003-01-27
• Last updated: 2020-10-19

Locations

55 sites across 1 country: United States