Back to resultsCAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
Primary Purpose
Cervix Cancer
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
campto (irinotecan)
cisplatin (cisplatyl)
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Cancer focused on measuring cervix cancer, advanced cervix cancer, radiochemotherapy, pelvic radiotherapy, campto, cisplatin, irinotecan, cisplatyl, maximum dose search
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
Sites / Locations
- CRLC Val d'Aurelle
- Centre Claudius Régaud
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00251888
First Posted
November 10, 2005
Last Updated
January 24, 2017
Sponsor
ARCAGY/ GINECO GROUP
1. Study Identification
Unique Protocol Identification Number
NCT00251888
Brief Title
CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ARCAGY/ GINECO GROUP
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer
Keywords
cervix cancer, advanced cervix cancer, radiochemotherapy, pelvic radiotherapy, campto, cisplatin, irinotecan, cisplatyl, maximum dose search
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
campto (irinotecan)
Intervention Type
Drug
Intervention Name(s)
cisplatin (cisplatyl)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate :
Title
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
Title
local and general relapse frequency
Title
progression free survival
Title
global survival
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Hennequin, Physician
Organizational Affiliation
Hôpital St Louis, Paris, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadine Dohollou, physician
Organizational Affiliation
Clinique Bordeaux Nord, Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Claudius Régaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
12. IPD Sharing Statement
Learn more about this trial
CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
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