CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
gemcitabine, docetaxel, doxorubicindrug
Likely dose
Gemcitabine and docetaxel (cycles 1–4), followed by doxorubicin (cycles 5–8), 28-day cyclesAI-extracted
Key inclusion· 8
  • ✓Age ≥18 years
  • ✓Histologically confirmed high-risk uterine leiomyosarcoma, FIGO stage I or II, with high grade and/or mitotic rate ≥5 mitoses/10 hpf
  • ✓Enrollment within 12 weeks of complete surgical resection with no residual disease
  • ✓ECOG performance status 0 or 1
Key exclusion· 6
  • ✕Prior invasive malignancy
  • ✕Prior chemotherapy with gemcitabine, docetaxel, or doxorubicin
  • ✕Hypersensitivity to docetaxel or polysorbate 80–formulated drugs
  • ✕Cardiac ejection fraction <50%

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00282087
NCT00282087Phase 2Completed
CompareCT.gov

Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial

Sarcoma Alliance for Research through Collaboration·interventional·Posted Jan 25, 2006·Updated Dec 1, 2014

In Brief

A Phase 2 clinical trial evaluating gemcitabine, docetaxel, doxorubicin for Leiomyosarcoma and Uterine Neoplasm. Completed, enrolled 47 participants across 12 sites.

Detailed Summary

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyosarcoma, Uterine Neoplasm
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 20.4 years ago

Interventions

gemcitabine, docetaxel, doxorubicindrug

Cycles = 28 days