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

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

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)