Clinical Trial: Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Directe

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 Summary:

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.


Sponsor: Women's Cancer Care Associates, LLC

Current Primary Outcome: Recurrence-free survival (RFS) [ Time Frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years ]

RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall survival (OS) [ Time Frame: from study entry to death or date of last contact, assessed up to 8 years ]

OS assessed by the contact with patient in person or by telephone


Original Secondary Outcome: Same as current

Information By: Women's Cancer Care Associates, LLC

Dates:
Date Received: July 9, 2015
Date Started: March 2015
Date Completion: March 2023
Last Updated: October 31, 2016
Last Verified: October 2016