A Phase 1/2 interventional study of fluorouracil and hydroxyurea in Esophageal Cancer, sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. Status unknown at 14 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-02-09.
Sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group · Phase 1/2, Interventional, and Treatment
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to weight loss (less than 10% vs at least 10%) and inoperability criteria (nonresectable vs due to anatomical terrain). Patients are randomized to one of two treatment arms.
Treatment continues every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with possible resectable disease undergo surgical resection at 4-6 weeks following the last course of chemoradiotherapy. Patients with continued unresectable disease receive 2 additional courses of chemoradiotherapy as above within 8-17 days following the last course of chemoradiotherapy.
Quality of life is assessed at baseline, monthly during therapy, every 2 months for 6 months, every 4 months for 1 year, and then every 6 months thereafter.
Patients are followed every 2 months for 6 months, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
Browse Esophageal Neoplasms studies →GERCOR - Multidisciplinary Oncology Cooperative Group is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
No extension to the tracheo-bronchial pathway
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is status unknown, as verified in Feb 2001. You cannot join it, but the record below documents what was studied.
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GERCOR - Multidisciplinary Oncology Cooperative Group