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

Centre Oscar Lambret

Status and phase

Terminated

Phase 2

Conditions

Uterine Cervical Cancer

Treatments

Drug: Cisplatin

Procedure: Radiotherapy

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

GEMCOL 0401

Details and patient eligibility

About

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

Enrollment

19 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)