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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00251888 |
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Date of registration:
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10/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
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Scientific title:
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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. |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00251888 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Christophe Hennequin, Physician |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital St Louis, Paris, France |
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Name:
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Nadine Dohollou, physician |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique Bordeaux Nord, Bordeaux, France |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervix Cancer
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Intervention(s)
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Drug: campto (irinotecan)
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Drug: cisplatin (cisplatyl)
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Primary Outcome(s)
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To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
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Secondary Outcome(s)
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To evaluate :
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progression free survival
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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
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global survival
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local and general relapse frequency
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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