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
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)