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

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

Official Title
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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

Conditions
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Uterine Cervical Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Procedure: Radiotherapy
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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 prior chemotherapy or radiotherapy Contraception Written informed consent signed Exclusion Criteria: Stage IB < 4 cm or IVB Other histology than epidermoid or adenocarcinoma Distant metastases, including sus-clavicular adenopathy Contraindication to MRI Pregnant or lactating woman Auto-immune disease Peripheric neuropathy, autograft or homograft, psychiatric disease Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ) Active infection Other clinical trial with an experimental drug Known positive serology (HIV, HbC, HbS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with cervix cancer<br>will receive gemcitabine + cisplatin + radiotherapy | Drug: Gemcitabine<br>* 125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.<br>Procedure: Radiotherapy<br>* 45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy) +/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area<br>Drug: Cisplatin<br>* 40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 3 years after the end of study treament | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global survival |  | 5 years after the end of study treatment | 
| safety |  | untill 5 years after study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterine cervical cancer