Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer

Amendment history

1. Sep 15, 2026

   Minor

   Eligibility criteria shortened, about 4 words

   Show what changed: Eligibility criteria

   Inclusion Criteria: * Age between 18 and 70 years old * Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB\> or = 4 cm to IV, according to FIGO classification) histologically proven * Measurable lesions,clinically and by MRI assessed * PS-WHO < or = 2 ou Karnofsky Index >\70 per cent * Life expectancy \> 3 months * Hematologic function: leukocytes < or = 3 G/l, polynuclear neutrophil leukocytes >\ or = 1.5 G/l, platelets \> or = 100 G/l, hemoglobin \> or = 10 g/dl * Hepatic function: ASAT and ALAT < 2.5 ULN Renal function: creatininemia < 1.5 ULN, clearance >\ 60 ml/min * No [...] [...]

2. Mar 12, 2026

   Minor

   2 amendments

   2 re-verifications since 2012-07-23, no change to tracked fields

   v4-v5

3. Jul 20, 2012

   Minor

   Interventions: Cisplatine (Drug), Gemcitabine (Drug), Radiotherapy (Procedure) to Cisplatin (Drug), Gemcitabine (Drug), Radiotherapy (Procedure)

   Eligibility criteria revised; Study description shortened, about 9 words; Study arms: 0 to 1

   Show what changed: Eligibility criteria

   [...] tologically proven Measurable lesions,clinically and by MRI assesssedassessed PS-WHO < or = 2 ou Karnofsky Index >70 per cent Life expect [...]

   Show what changed: Study description

   Further study details as provided by Centre Oscar Lambret

   Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Eligibility · v3

4. May 18, 2009

   Stopped

   Trial status: Recruiting to Terminated

   Sponsor's reason: Problems of recruitment

   Enrollment target: 73 to 19; Primary completion date: Apr 2008; Completion date: May 2013 to Dec 2011; and 2 more

   Show all 6 changes in this update

   • Stopped Trial status: Recruiting to Terminated
   • Notable Enrollment target: 73 to 19
   • Minor Primary completion date: Apr 2008
   • Minor Completion date: May 2013 to Dec 2011
   • Minor Secondary endpoints: 1 to 2
     Show what changed

     safety
   • Minor Site details revised at 2 of 2 sites

   Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations · v2

5. Jan 10, 2007

   Minor

   Study First Submitted

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.