A Phase I Evaluation of Extended Field Radiation Therapy with Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women with Cervical Carcinoma Metastatic to Para-Aortic Lymph Nodes
Principal Investigator
Cecelia Boardman, MD
Status
Terminated
Date Opened To Accrual
April 09 2012
Date Closed to Accrual
May 19 2014
Date of Study Termination
February 09 2019
Disease Site
Gynecologic [GY]
Cervix
Phase
I
Developmental Therapeutics
No
Primary Objective
To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of adjuvant carboplatin and paclitaxel chemotherapy following concurrent weekly cisplatin chemotherapy and extended field radiation in women with newly diagnosed Stage IB-IVA cervical cancer, with positive para-aortic nodes.
To determine the feasibility of the treatment regimen over the four cycles of adjuvant chemotherapy once the MTD in estimated.
To assess the toxicities of the treatment regimen the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Patient Population
Women with newly diagnosed Stage IB-IVA cervical cancer, with positive para-aortic nodes.
Target Accrual
45
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.