Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.
Stage IA Uterine Sarcoma
Stage IB Uterine Sarcoma
Stage IC Uterine Sarcoma
Stage IIA Uterine Sarcoma
Stage IIB Uterine Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Radiation: external beam radiation therapy
Radiation: intensity-modulated radiation therapy
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma|
- Recurrence-free survival [ Time Frame: Date of entry to date of reappearance of disease, assessed at 1 year ] [ Designated as safety issue: No ]One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (paclitaxel, carboplatin, radiotherapy)
CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.
RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.
Other Names:Drug: carboplatin
Other Names:Radiation: external beam radiation therapy
Undergo external beam radiation therapy
Other Name: EBRTRadiation: brachytherapy
Undergo HDR brachytherapy
Other Names:Radiation: intensity-modulated radiation therapy
Other Name: IMRTOther: laboratory biomarker analysis
I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.
II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.
III. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.
CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.
RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367301
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Merieme Klobocista 718-405-8082 email@example.com|
|Principal Investigator: Merieme Klobocista|
|Principal Investigator:||Merieme Klobocista||Albert Einstein College of Medicine of Yeshiva University|