SARC005

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

TYPE OF SARCOMA: Uterine Leiomyosarcoma
DRUG: Gemcitabine and Docetaxel

ACCRUAL STATUS: Completed

OVERALL STUDY PRINCIPAL INVESTIGATOR:
Martee L. Hensley, MD
Memorial Sloan Kettering Cancer Center

CLINICALTRIALS.GOV IDENTIFIER: NCT00282087

FOR STUDY DETAILS AND ELIGIBILITY CRITERIA: CLINICALTRIALS.GOV

IMPACT STATEMENT:
Women with uterine-confined, high-grade leiomyosarcoma have a 50-70% chance of recurrence.  Doxorubicin, and gemcitabine-docetaxel, are active treatment regimens for metastatic leiomyosarcoma.  SARC 005 was a phase II study investigating whether the adjuvant use of these agents might decrease the risk for sarcoma recurrence in women with uterine LMS.  The results of SARC 005 were used to support the development of a phase III trial of adjuvant gemcitabine-docetaxel followed by doxorubicin v. observation for women with uterine-confined high-grade LMS (GOG 0277).  The results of GOG 0277 showed that adjuvant chemotherapy did not improve survival outcomes compared with observation.

PUBLICATION:
Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18. PMID: 23335221.

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