Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
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|ClinicalTrials.gov Identifier: NCT01367301|
Recruitment Status : Unknown
Verified January 2015 by Merieme Klobocista, Albert Einstein College of Medicine.
Recruitment status was: Recruiting
First Posted : June 7, 2011
Last Update Posted : January 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|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 Uterine Carcinosarcoma||Drug: paclitaxel Drug: carboplatin Radiation: external beam radiation therapy Radiation: brachytherapy Radiation: intensity-modulated radiation therapy Other: laboratory biomarker analysis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||January 2016|
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.
Radiation: external beam radiation therapy
Undergo external beam radiation therapy
Other Name: EBRT
Undergo HDR brachytherapy
Radiation: intensity-modulated radiation therapy
Other Name: IMRT
Other: laboratory biomarker analysis
- Recurrence-free survival [ Time Frame: Date of entry to date of reappearance of disease, assessed at 1 year ]One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367301
|United States, New York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Merieme Klobocista 718-405-8082 firstname.lastname@example.org|
|Principal Investigator: Merieme Klobocista|
|Principal Investigator:||Merieme Klobocista||Albert Einstein College of Medicine|