Status:
TERMINATED
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Uterine Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00421096
Start Date
May 1 2005
End Date
December 1 2011
Last Update
July 24 2012
Active Locations (2)
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1
Centre Leonard de Vinci
Dechy, France, 59187
2
Centre Oscar Lambret
Lille, France, 59020