Spots Global Cancer Trial Database for Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

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Trial Identification

Brief Title: Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

Official Title: A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma

Study ID: NCT01958580

Conditions

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

Interventions

Gemcitabine Hydrochloride

Docetaxel

Internal Radiation Therapy

Intensity-Modulated Radiation Therapy

External Beam Radiation Therapy

Laboratory Biomarker Analysis

Study Description

Brief Summary: This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.

Detailed Description: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.