Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer (NCT00421096) | Clinical Trial Compass
TerminatedPhase 2
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
Stopped: Problems of recruitment
France19 participantsStarted 2005-05
Plain-language summary
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Progression-free survival
Timeframe: 3 years after the end of study treament