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 Tumour Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumour Volume Directed Irradiation Then Further Carboplatin and Paclitaxel

Summary:

To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.

Trial Description

Primary Outcome:

• Recurrence-free survival (RFS)

Secondary Outcome:

• Overall survival (OS)

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.

View this trial on ClinicalTrials.gov