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

Alternate Title

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	CALGB-80101 NCCTG-CALGB-80101, ECOG-CALGB-80101, NCT00052910

Special Category: CTSU trial

Objectives

1. Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy.
2. Compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.
3. Correlate the expression of putative prognostic markers (including TS, ERCC-1, MSI, E-cadherin, EGFR, p27, COX-2, and c-erbB-2) with overall survival of patients treated with these regimens.
4. Correlate specific germline polymorphisms related to chemotherapy metabolism and resistance (including UGT2B7 [epirubicin], GST [cisplatin], ERCCI [cisplatin], XRCC1 [cisplatin], TS [5-FU], DPD [5-FU], and EGFR polymorphisms) with treatment-related toxicity and overall survival of these patients.
5. Correlate serum levels of insulin-like growth factor-1 (IGF-1), IGF-2, and IGF-binding protein 3 with overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (adenocarcinoma of the esophagus must involve the gastroesophageal junction) meeting the following criteria:
  • Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
  • Stage II, IIIA, IIIB, or IV (T2, N2, M0)
  • Stage IB (T1, N1, M0; T2, N0, M0 allowed if extension beyond muscularis propia)



• Prior en bloc resection, with curative intent, of all known tumor
  • No microscopic evidence of tumor at the line of resection
  • No noncontiguous resection



• No known unresected or recurrent disease at the distal or proximal line of stomach resection



• No metastatic disease

Prior/Concurrent Therapy:

Biologic therapy

• Prior biologic therapy allowed

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• Prior hormonal therapy allowed
• No concurrent hormonal therapy except the following:
  • Steroids for adrenal failure
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Intermittent dexamethasone as an antiemetic

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics
• At least 3 weeks since prior surgery
• No more than 12 weeks since prior surgery

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST no greater than 3 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL
• No unilateral renal function

Cardiovascular

• No myocardial infarction within the past 6 months
• No uncontrolled high blood pressure
• No unstable angina
• No symptomatic congestive heart failure
• No serious uncontrolled cardiac arrhythmia
• No New York Heart Association class III or IV heart disease
• No cardiac disease resulting in marked limitation or inability of physical activity

Other

• Stable weight for at least one week before study
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or fully resected noninvasive carcinoma in situ
• No other uncontrolled serious medical condition or psychiatric illness that would preclude study entry
• No active infection
• No peripheral neuropathy grade 2 or greater

Expected Enrollment

A total of 824 patients will be accrued for this study.

Outcomes

Overall survival

Outline

This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days between course 2 and 3.



• Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.

Fuchs C, Tepper JE, Niedwiecki D, et al.: Postoperative adjuvant chemoradiation for gastric or gastroesophageal adenocarcinoma using epirubicin, cisplatin, and infusional (CI) 5-FU (ECF) before and after CI 5-FU and radiotherapy (RT): interim toxicity results from Intergroup trial CALGB 80101. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-61, 2006.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Charles Fuchs, MD, Protocol chair		Ph: 617-632-5840; 866-790-4500

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-2511

Eastern Cooperative Oncology Group

Daniel Haller, MD, Protocol chair		Ph: 215-662-6318

Registry Information
Official Title		Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Trial Start Date		2002-12-15
Trial Completion Date		2007-06-20 (estimated)
Registered in ClinicalTrials.gov		NCT00052910
Date Submitted to PDQ		2002-11-06
Information Last Verified		2009-06-01
NCI Grant/Contract Number		CA31946

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