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Brief Title: Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol
Official Title: Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel
Study ID: NCT02501954
Brief Summary: To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.
Detailed Description: To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm). To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm). To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Munson Health Care, Traverse City, Michigan, United States
Atlantic Health, Morristown, New Jersey, United States
Women's Cancer Care Associates, LLC, Albany, New York, United States
The Ohio State University, Columbus, Ohio, United States
Gunderson Lutheran Medical Foundation, La Crosse, Wisconsin, United States
CHUM Hopital Notre-Dame, Montréal, Quebec, Canada
Name: Joyce N Barlin, MD
Affiliation: Women's Cancer Care Associates, LLC
Role: PRINCIPAL_INVESTIGATOR