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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?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- 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
resection

- No metastatic disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

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

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

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 3 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

- No unilateral renal function

Cardiovascular

- 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

Other

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior biologic therapy allowed

Chemotherapy

- 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

Radiotherapy

- No prior radiotherapy

Surgery

- 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
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Saint Anne's Hospital - Active, not recruiting
  • Morton Hospital - Active, not recruiting
Trial Interventions
Drug
  • cisplatin
  • epirubicin hydrochloride
  • fluorouracil
  • leucovorin calcium
Radiation
  • 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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