Status:
COMPLETED
Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Stomach Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed...
Detailed Description
* Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment. 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump (CADD pump) for 2...
Eligibility Criteria
Inclusion
- Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
- Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected.
- The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging.
- Treatment must begin between day 20 and day 56 after the gastrectomy.
- ECOG performance status of 0,1 or 2
- ANC \> 1,500/ul and platelet count \>100,000/ul
- Serum creatinine \< 1.5mg/dl
- Total bilirubin \< 2.0 mg/dl and AST \< 3 x ULN
- Estimated caloric intake of 1500K calories per day or greater
Exclusion
- Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease
- Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years
- Previous chemotherapy or radiotherapy
- Active infectious process
- Pregnant or lactating women
- Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease
- Uncontrolled serious medical or psychiatric condition
- Grade 2 or greater peripheral neuropathy at baseline
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00215514
Start Date
September 1 2000
End Date
July 1 2014
Last Update
July 29 2014
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115