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Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma

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Trial Conditions
  • Esophageal Cancer
  • Gastric Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer. PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
(adenocarcinoma of the esophagus must involve the gastroesophageal junction) meeting
the following criteria:

- Tumor extension beyond muscularis propria and/or nodal involvement without
evidence of M1 disease

- Stage II, IIIA, IIIB, or IV (T2, N2, M0)

- Stage IB (T1, N1, M0; T2, N0, M0 allowed if extension beyond muscularis propia)

- Prior en bloc resection, with curative intent, of all known tumor

- No microscopic evidence of tumor at the line of resection

- No noncontiguous resection

- No known unresected or recurrent disease at the distal or proximal line of stomach

- No metastatic disease



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 3 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL

- No unilateral renal function


- No myocardial infarction within the past 6 months

- No uncontrolled high blood pressure

- No unstable angina

- No symptomatic congestive heart failure

- No serious uncontrolled cardiac arrhythmia

- No New York Heart Association class III or IV heart disease

- No cardiac disease resulting in marked limitation or inability of physical activity


- Stable weight for at least one week before study

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or fully resected noninvasive carcinoma in situ

- No other uncontrolled serious medical condition or psychiatric illness that would
preclude study entry

- No active infection

- No peripheral neuropathy grade 2 or greater

- All patients must be evaluated by a radiation oncologist prior to enrollment to
ensure patient is appropriate for radiotherapy


Biologic therapy

- Prior biologic therapy allowed


- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Prior hormonal therapy allowed

- No concurrent hormonal therapy except the following:

- Steroids for adrenal failure

- Hormones for non-disease-related conditions (e.g., insulin for diabetes)

- Intermittent dexamethasone as an antiemetic


- No prior radiotherapy


- See Disease Characteristics

- At least 3 weeks since prior surgery

- No more than 12 weeks since prior surgery

Gender: Both
Steward Physician(s)
  • Charles S. Fuchs, MD
  • Steven R. Alberts, MD
  • Daniel G. Haller, MD
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Saint Anne's Hospital - Active, not recruiting
  • Morton Hospital - Active, not recruiting
Trial Interventions
  • cisplatin
  • epirubicin hydrochloride
  • fluorouracil
  • leucovorin calcium
  • radiation therapy
Physician Researcher

Investigator Name:

  • Charles S. Fuchs, MD
  • Steven R. Alberts, MD
  • Daniel G. Haller, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00052910
Volunteers:  Not Accepting Healthy Volunteers

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