CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
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.
1 other identifier
interventional
15
1 country
2
Brief Summary
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2002
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedJanuary 25, 2017
February 1, 2011
November 10, 2005
January 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CRLC Val d'Aurelle
Montpellier, 34298, France
Centre Claudius Régaud
Toulouse, 31052, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe Hennequin, Physician
Hôpital St Louis, Paris, France
- PRINCIPAL INVESTIGATOR
Nadine Dohollou, physician
Clinique Bordeaux Nord, Bordeaux, France
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 11, 2005
Study Start
November 1, 2002
Study Completion
November 1, 2005
Last Updated
January 25, 2017
Record last verified: 2011-02