Status:
COMPLETED
CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
Lead Sponsor:
ARCAGY/ GINECO GROUP
Conditions:
Cervix Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.
Detailed Description
To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced ce...
Eligibility Criteria
Inclusion
- Histologically proven primitive epidermoid or andenocarcinoma Cervix
- FIGO stage IIB (obviously parameter attack), III or IVA
- No previous chemotherapy nor radiotherapy
- Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
- PS ECOG \< 2
- Life expectancy \> 12 weeks
- Written consent given
Exclusion
- Other malignant cervix tumor histology
- Visceral remotly metastasis
- Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
- Anormal labs values
- Peripheric neuropathy CTC \> 2
- Auditory loss \> 2
- Cardiopathy
- Inflammatory digestive pathology
- Evolutive infection
- Other experimental concommitant treatment
- Lacting or pregnant women
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00251888
Start Date
November 1 2002
End Date
November 1 2005
Last Update
January 25 2017
Active Locations (2)
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1
CRLC Val d'Aurelle
Montpellier, France, 34298
2
Centre Claudius Régaud
Toulouse, France, 31052