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

ARCAGY/ GINECO GROUP15 enrolled

Overview

Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervix Cancer

Interventions

campto (irinotecan)DRUG

cisplatin (cisplatyl)DRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CRLC Val d'Aurelle

Montpellier, France

Centre Claudius Régaud

Toulouse, France

Outcomes

Primary Outcomes

To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer

Secondary Outcomes

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

Data from ClinicalTrials.gov

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