Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215514
• Other study ID #: 00-165
• Status: Completed
• Phase: Phase 0
• First received: September 20, 2005
• Last updated: July 28, 2014
• Start date: September 2000
• Est. completion date: July 2014

Study information

• 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

Clinical Trial 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 by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.

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 21 days. This cycle of chemotherapy will take 21 days (3 weeks). Once it is complete there will be one week without therapy.

• Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy, 5-fluorouracil and radiation. The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located. The radiation therapy will be given five days a week for a total of five weeks. During these five weeks patients will receive 5-fluorouracil continuously by CADD pump.

• After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle.

• The following tests and procedures will be performed: physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly; blood tests every week during chemotherapy and chemoradiation; CT scans and chest x-rays done before therapy, at the end of therapy, and yearly for 2 years; noninvasive testing to evaluate kidney function before starting the study.

• The program of chemotherapy and radiation therapy will last approximately 30 weeks. After all treatment is completed, patients will return for physical examinations and blood tests every 3 months for 3 years; then every 6 months for 2 years.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Gastro-esophageal Junction Cancer
• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• Epirubicin
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
• Cisplatin
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
• 5-Fluorouracil (5-FU)
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

Procedure:
• Radiation
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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