CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Gemcitabinedrug
Likely dose
Gemcitabine weekly for 6 weeks with concurrent external radiationAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed bulky stage IB (tumor >4 cm) or stage IIa cervical cancer
  • ✓Cervical lesion measurable by physical examination
  • ✓No prior therapy for invasive cervical cancer
  • ✓GOG performance status 0-2
Key exclusion· 5
  • ✕History of prior malignancy except basal cell or squamous cell skin carcinoma, or other cancer disease-free for ≥5 years
  • ✕Pregnant or lactating women
  • ✕Uncontrolled infection
  • ✕HIV positive status

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

Search/NCT00184093
NCT00184093Phase 2Completed
CompareCT.gov

Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study

University of Southern California·interventional·Posted Sep 16, 2005·Updated Aug 15, 2017

In Brief

A Phase 2 clinical trial evaluating Gemcitabine for Uterine Cervical Cancer. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Cervical Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJun 1, 1999
Primary CompletionMay 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

Gemcitabine weekly x 6 wks with concurrent external radiation