Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Charles S. Fuchs, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00215514
First received: September 20, 2005
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Stomach Cancer
Gastric Cancer
Gastro-esophageal Junction Cancer
Drug: Epirubicin
Drug: Cisplatin
Drug: 5-Fluorouracil (5-FU)
Procedure: Radiation
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: September 2000
Estimated Study Completion Date: December 2013
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECF followed by 5-FU/RT followed by ECF 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).
Drug: 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).
Drug: 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).

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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215514

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Charles S. Fuchs, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Charles S. Fuchs, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00215514     History of Changes
Other Study ID Numbers: 00-165
Study First Received: September 20, 2005
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
adjuvant chemoradiation
GE junction
epirubicin

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Epirubicin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014