NCT00421096

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

Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy

Conditions

• Uterine Cervical Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
PROCEDURE	Radiotherapy	45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy) +/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area
DRUG	Cisplatin	40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-04-01
• Completion: 2011-12-01
• First posted: 2007-01-11
• Last updated: 2026-03-13

Locations

2 sites across 1 country: France