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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Treatments: Cisplatin; Gemcitabine

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 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)