RADIATION + CISPLATIN VS RADIATION + 5-FU IN CERVIX CA

Tulane University Of Louisiana, New Orleans LA

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Abstract

This multi-center, randomized study is a comparison of radiation plus weekly cisplatin versus radiation plus PVI (protracted venous infusion)5-FU in patients with stage IIB, IIIB, and IVA carcinoma of the cervix. Cancer of the uterine cervix is the second most common cancer in females, representing 15% of all female cancers, 80% of which are diagnosed in underdeveloped countries. In the U. S., cervical cancer is the third most common gynecologic malignancy. The vast majority of cases are diagnosed with early stage disease, but many still present with locally advanced disease which requires radiation. The aims of this study are to compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis receiving radiation plus prolonged venous infusion (PVI) 5-FU with radiation plus weekly cisplatin; to determine the relative toxicities of radiation plus chemotherapy using either weekly cisplatin or PVI 5-FU; to compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who: a)smoke at the time of diagnosis versus non-smokers or b) smoke during radiation therapy versus those who quit; and to collect data regarding clinical outcomes and hemoglobin levels during chemoradiotherapy.