CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto

Study Overview
=================
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 cervix cancer, IIB-IVA FIGO stage.

Official Title
-----------------
Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.

Conditions
-----------------
Cervix Cancer

Intervention / Treatment
-----------------
* Drug: campto (irinotecan)
* Drug: cisplatin (cisplatyl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: campto (irinotecan)|nan|
|Drug: cisplatin (cisplatyl)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate : |  |  | 
| the global response rate judged on standard clinical criteria, echography, tomodensiometry, and MRI. The histologic response rate will be appreciated in patients who had a second surgery after pelvic radiochemotherapy |  |  | 
| local and general relapse frequency |  |  | 
| progression free survival |  |  | 
| global survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervix cancer, advanced cervix cancer, radiochemotherapy, pelvic radiotherapy, campto, cisplatin, irinotecan, cisplatyl, maximum dose search