Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery
|ClinicalTrials.gov Identifier: NCT01958580|
Recruitment Status : Unknown
Verified January 2015 by Merieme Klobocista, Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was: Recruiting
First Posted : October 9, 2013
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 Corpus Leiomyosarcoma||Drug: Gemcitabine Hydrochloride Drug: Docetaxel Radiation: Internal Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis||Not Applicable|
I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma.
I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen.
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks.
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 Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Experimental: Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
Drug: Gemcitabine Hydrochloride
Other Names:Drug: Docetaxel
Other Name: TXTRadiation: Internal Radiation Therapy
Other Names:Radiation: Intensity-Modulated Radiation Therapy
Other Names:Radiation: External Beam Radiation Therapy
Other Names:Other: Laboratory Biomarker Analysis
- Recurrence-free survival [ Time Frame: Date of entry to date of reappearance of disease, assessed at 2 years ]Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958580
|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, Inc.|