Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus
Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.
The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).
Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).
It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.
Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus|
- Phase I = determination the maximum tolerated dose 5FU and panitumumab in combination with radiotherapy and mitomycin, and thereby to deduce the maximum tolerated dose in patient with localised epidermoid carcinoma of the anus [ Time Frame: 9 weeks after the beginning of treatment ] [ Designated as safety issue: No ]Phase I = determine the dose limiting toxicity of 5FU and panitumumab in combination with radiotherapy and mitomycin, and thereby to deduce the maximum tolerated dose in patient with localised epidermoid carcinoma of the anus
- Phase II = Complete response of the tumor rectal examination and morphological exams [ Time Frame: 8 weeks evaluations after the end of the treatment by radiochemotherapy ] [ Designated as safety issue: No ]phase II = Response criteria: complete desappearance of the tumor upon rectal examination and morphological exams (MRI, endoscopic ultrasonography) and non appearance of secondary lesions, response validated by an independant committee.
- Phase II = Partial response rate, stable disease and progression [ Time Frame: 6 weeks and 17 weeks after the beginning of treatment ] [ Designated as safety issue: No ]
- Intermediate objective response rate (complete and partial) at 6 weeks (before the additional radiotherapy). The 80% reduction rate in the largest tumour diameter will also be recorded.
- Partial response rate, stable disease and progression 8 weeks after the end of treatment
- Phase II = Colostomy-free survival [ Time Frame: At 3 years after randomization ] [ Designated as safety issue: No ]
- Phase II = Recurrence-free survival at 3 years [ Time Frame: At 3 years after randomization ] [ Designated as safety issue: No ]
- Phase II = Overall survival [ Time Frame: At 3 years after randomization ] [ Designated as safety issue: No ]
- Phase II = Quality of life (EORTC QLQ-C30 + Wexner questionnaire) [ Time Frame: At 3 years after randomization ] [ Designated as safety issue: No ]-
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: 5Fu-mitomycine-panitumumab + radiotherapy
5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10
Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²Drug: Panitumumab
3 or 6 mg/kg (according to dose level)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581840
|Contact: MOREAU Marie||+33 3 80 39 34 firstname.lastname@example.org|
|Fédération Francophone de Cancérologie Digestive||Recruiting|
|Dijon, Bourgogne, France, 21000|
|Contact: MOREAU Marie +33 3 80 39 34 04 email@example.com|
|Principal Investigator:||APARICIO Thomas, MD - PhD||CHU Avicenne - Bobigny - APHP|