To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Given IV
Given IV
Given IV
Undergo Radiation Therapy
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
Montreal, Quebec, Canada
Recurrence-free survival (RFS)
RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.
Time frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years
Overall survival (OS)
OS assessed by the contact with patient in person or by telephone
Time frame: from study entry to death or date of last contact, assessed up to 8 years
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