A PHASE III RANDOMIZED TRIAL OF GEMCITABINE PLUS DOCETAXEL FOLLOWED BY DOXORUBICIN V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

Phase 3

Withdrawn

Conditions: leiomyosarcoma
uterine
10038597

Registration Number: NL-OMON41992

Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

Patients with a high risk of uterine leiomyosarcoma FIGO stage I.
Institutional pathology review of leiomyosarcoma
Al patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study.
Age > 18 years
Written informed consent

Exclusion Criteria

Patient who had prior therapy with docetaxel or gemcitabine or doxorubicine
Patient with a history of malignancy being present within the last 5 years
Patient with a history of severe hypersensitivity reaction to anthracenedione/anthracyclines or drugs containing polysorbate 80 excipients are not allowed to participate in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine whether overall survival of patients with uterus-limited<br /><br>high-grade leiomyosarcoma is superior among patients assigned to<br /><br>treatment with adjuvant gemcitabine plus docetaxel followed by<br /><br>doxorubicin compared to patients assigned to observation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine whether treatment with adjuvant gemcitabine plus docetaxel<br /><br>followed by doxorubicin improves recurrence-free survival of patients<br /><br>with uterus-limited high-grade leiomyosarcoma compared to observation.<br /><br><br /><br><br /><br>To explore the impact of potential predictors of recurrence or death such<br /><br>as patient age, and institution reported tumor size, cervix involvement (yes<br /><br>or no), and mitotic rate.</p><br>