This multicenter Phase II study hopes to confirm single institutional reports of whether radiation therapy (RT) to the groin combined with chemotherapy in patients with squamous or epidermoid carcinomas of the vulva will permit less extensive surgery than previously recommended. Surgery for these patients in the past involved local lymph node removal and frequently removal of parts of the anus, rectum, urethra, bladder, clitoris and vagina, depending on the extent of local spread. The patients will undergo RT 5 out of 7 days, to the local area coupled with two weeks of chemotherapy with 5-FU and Mitomycin-C. If there is sufficient tumor regression to allow for simple surgery, it will be performed 6 to 8 weeks after the course has been finished. If not, they will add 10 more RT treatments in conjuction with a third course of chemotherapy. Patients wilth nodal involvement will undergo resection of involved nodes followed by the above protocol. The objectives of this study are to assess the efficacy of this therapy as having less morbidity than conventional therapy, to measure the efficacy of initial chemoradiation in converting the status of locally advanced cancers of the vulva from unresectable to resectable.The following endpoints will be measured: freedom from relapse in groin nodes; rate of chemoradiotherapeutic conversion of locally extensive vulvar cancer from unresectable to resectable; freedom from relapse at the primary site, acute toxicities of treatment and late effects in normal tissues; and pattern of failure and causes of death.
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