| Trial Name: |
CALGB 80101
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| Intro: |
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastrointestinal Adenocarcinoma |
| Condition: |
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| Description: |
This study will determine whether overall survival is prolonged in patients with resected gastric adenocarcinoma who receive epirubicin, cisplatin, and infusional 5-FU (ECF) before and after infusional 5-FU plus radiotherapy (RT) when compared to those treated with bolus 5-FU and Leucovorin before and after infusional 5-FU plus RT. Patients will be randomized to one of two arms. Patients in Arm A will receive 5-FU and Leucovorin intravenously on days 1 through 5 of each 28-day cycle. Patients in Arm B will receive Epirubicin and cisplatin on day 1 of each cycle and 5-FU on days 1 through 21 of each cycle. Patients in both arms will receive 5-FU beginning on day one of RT and continuing until RT is completed. |
| Criteria: |
- Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction
- Patients must not have received any previous chemotherapy or radiotherapy
- Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical weight
- Patients must be evaluated by a radiation oncologist prior to enrollment to ensure that the patient is an appropriate candidate for radiation therapy
- Patients must have adequate cardiac function
- Patients must have adequate bone marrow, liver and renal function.
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| Contact: |
For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422 |
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All information regarding participation in Clinical Trials is treated with the
utmost confidentiality. University Hospitals Case Medical Center and the
Division of Clinical Research recognize and respect the confidentiality of this
information. Access to information related to clinical trials and their
participants is restricted to authorized clinical trials personnel only.
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