Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
NCT ID: NCT00421096
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2005-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patient with cervix cancer
will receive gemcitabine + cisplatin + radiotherapy
Gemcitabine
125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
Radiotherapy
45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)
+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area
Cisplatin
40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
Interventions
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Gemcitabine
125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
Radiotherapy
45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)
+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area
Cisplatin
40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
70 Years
FEMALE
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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BELKACEMI Yazid, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Leonard de Vinci
Dechy, , France
Centre Oscar Lambret
Lille, , France
Countries
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Other Identifiers
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GEMCOL 0401
Identifier Type: -
Identifier Source: org_study_id