drugset / Trial / NCT01581840

Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

NCT01581840

Phase 1/2 Completed 45 enrolled Federation Francophone de Cancerologie Digestive
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-01
Primary completion
2018-09
Completion
2021-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Panitumumab Monoclonal antibody 3 mg/kg
Subject Panitumumab Monoclonal antibody 6 mg/kg
Subject fluorouracil Small molecule 400 mg/m2
Subject fluorouracil Small molecule 600 mg/m2
Background Mitomycin C Other / unclassified 10 mg/m2