Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

Who is this study for? Adult patients with epidermoid carcinoma of the anus
What treatments are being studied? Radiochemotherapy+Panitumumab
Status: Completed
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically proven epidermoid carcinoma of the anus

• Locally advanced tumour without metastases

• Stage T2\>3 cm or T3 or T4, irrespective of N

• Stage N1-N3 irrespective of T stage (T1 to T4)

• General condition WHO 0-1

• Life expectancy \> 3 months

• Signed informed consent form

• Age \> 18 years

• Effective contraception in female and/or male patients having reached sexual maturity during treatment and up to 6 months after the end of treatment

• CD4 \> 400 / mm3

• Measureable tumor on at least one of the following exams : MRI, endoscopic ultrasonography, clinical exam

Locations
Other Locations
France
Pessac - Hôpital Haut Lévêque
Bordeaux
CH - Hopitaux civils de Colmar
Colmar
Centre d'oncologie et de radiothérapie du Parc
Dijon
Centre Oscar Lambret
Lille
CH - CHBS - Hôpital du Scorff
Lorient
Centre Léon Bérard
Lyon
Institut Régional du Cancer Montpellier
Montpellier
Clinique Privée - Plein Ciel
Mougins
Institut Curie
Paris
Cario - HPCA - Hôpital privé des Côtes D'Armor
Plérin
CH - Annecy Genevois
Pringy
Centre Eugène Marquis
Rennes
Institut Curie
Saint Cloud
CHU
Saint Priest En Jarez
CAC - Paul Strauss
Strasbourg
Time Frame
Start Date: 2016-01
Completion Date: 2021-02
Participants
Target number of participants: 45
Treatments
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
Sponsors
Leads: Federation Francophone de Cancerologie Digestive

This content was sourced from clinicaltrials.gov

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