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

Phase 0
18 Years
Open (Enrolling)
Stomach Cancer, Gastric Cancer, Gastro-esophageal Junction Cancer

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Trial Information

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

- 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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Charles S. Fuchs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2000

Completion Date:

December 2013

Related Keywords:

  • Stomach Cancer
  • Gastric Cancer
  • Gastro-esophageal Junction Cancer
  • adjuvant chemoradiation
  • GE junction
  • epirubicin
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Stomach Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617