Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
Phase 2
Terminated
- Conditions
- Uterine Cervical Cancer
- Interventions
- Registration Number
- NCT00421096
- Lead Sponsor
- Centre Oscar Lambret
- Brief Summary
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 19
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patient with cervix cancer Gemcitabine will receive gemcitabine + cisplatin + radiotherapy patient with cervix cancer Radiotherapy will receive gemcitabine + cisplatin + radiotherapy patient with cervix cancer Cisplatin will receive gemcitabine + cisplatin + radiotherapy
- Primary Outcome Measures
Name Time Method Progression-free survival 3 years after the end of study treament
- Secondary Outcome Measures
Name Time Method Global survival 5 years after the end of study treatment safety untill 5 years after study treatment
Trial Locations
- Locations (2)
Centre Leonard de Vinci
🇫🇷Dechy, France
Centre Oscar Lambret
🇫🇷Lille, France