A Phase 2 interventional study of fluorouracil and hydroxyurea in Esophageal Cancer and Head and Neck Cancer, sponsored by University of Chicago. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2013-09-05.
Sponsored by University of Chicago · Phase 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 radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.
OBJECTIVES:
OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.
The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 53 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
Drug: fluorouracil · Drug: hydroxyurea · Procedure: surgical procedure · Radiation: radiation therapy
Locoregional control rate
Time frame: 8 years
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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University of Chicago