Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	RTOG-9904 RTOG-DEV-1046, NCT00003862, RTOG-99-04

Objectives

1. Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
2. Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
3. Determine the tolerability of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 16 weeks

Hematopoietic:

• Absolute granulocyte count greater than 2,000/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 21-49 patients will be accrued for this study within 2.5 years.

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.

Ajani JA, Winter K, Okawara GS, et al.: Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined modality therapy and pathologic response. J Clin Oncol 24 (24): 3953-8, 2006.[PUBMED Abstract]

Okawara GS, Winter K, Donohue JH, et al.: A phase II trial of preoperative chemotherapy and chemoradiotherapy for potentially resectable adenocarcinoma of the stomach (RTOG 99-04). [Abstract] J Clin Oncol 23 (Suppl 16): A-4019, 312s, 2005.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Jaffer Ajani, MD, Protocol chair		Ph: 713-792-2828; 800-392-1611 Email: jajani@mdanderson.org

Registry Information
Official Title		A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
Trial Start Date		1999-11-24
Registered in ClinicalTrials.gov		NCT00003862
Date Submitted to PDQ		1999-04-21
Information Last Verified		2003-09-30
NCI Grant/Contract Number		CA21661