Gastric Cancer Clinical Trial
Official title:
A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
Verified date | July 2014 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 2014 |
Est. primary completion date | November 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital, Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma. | 3 years | Yes |
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