Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Federation Francophone de Cancerologie Digestive45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epidermoid Carcinoma Anus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Presence of metastases * Previous anti-EGFR therapy * Stage T1N0 or T2 \< 3 cm N0 * History of pelvic radiotherapy * At least one of the following laboratory test results: Neutrophils \< 1500 /mm3, platelets \< 100 000 /mm3, Hb \< 9 g/dl, leukocytes \< 3000/mm3, blood bilirubin \> 1.5 times the upper limit of the normal range, transaminase (ASAT and ALAT) \> 2.5 times the upper limit of the normal range, creatinine clearance \< 50 mL/min (Cockcroft's formula Appendix x), Mg2+ \< the lower limit of the normal range, Ca2+ \< the lower limit of the normal range * Significant coronary artery disease or myocardial infarction in the past year * Follow-up not possible due to psychological or geographic reasons * History of interstitial pneumonitis or pulmonary fibrosis * History of malignant disease in the past five years apart from basocellular skin carcinoma or in situ cervical carcinoma having received adequate treatment * Pregnant or breast-feeding women, women of child-bearing potential not having taken a pregnancy test.

Locations (15)

Pessac - Hôpital Haut Lévêque

Bordeaux, France

CH - Hopitaux civils de Colmar

Colmar, France

Centre d'oncologie et de radiothérapie du Parc

Dijon, France

Centre Oscar Lambret

Lille, France

CH - CHBS - Hôpital du Scorff

Lorient, France

Centre Léon Bérard

Lyon, France

Institut Régional du Cancer Montpellier

Montpellier, France

Clinique Privée - Plein Ciel

Mougins, France

Institut Curie

Paris, France

Cario - HPCA - Hôpital privé des Côtes D'Armor

Plérin, France

...and 5 more locations

Outcomes

Primary Outcomes

Percentage of Patients With Complete Response to Treatment

Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee: * In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used; * in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint

Time frame: 8 weeks evaluations after the end of the treatment by radiochemotherapy

Secondary Outcomes

Percentage of Patients With Complete Response to Treatment

Time frame: 16 weeks after the end of the treatement by radiotherapy

3 Years Colostomy-free Survival (CFS)

It was defined as the time from inclusion to the date of colostomy or death (from any cause). Patients alive without colostomy were censored at date of last news. If a patient had a shunt colostomy and continuity wasrestored, the patient was counted among the patients without a colostomy.

Time frame: At 3 years after inclusion

Recurrence-free Survival (RFS) at 3 Years

It was defined as the time from inclusion to the date of first recurrence (local, regional, metastatic and second anal cancer) or death. Patients alive without recurrence were censored at date of last news.

Time frame: At 3 years after inclusion

Overall Survival (OS) at 12 Months

The percentage was evaluated at 12 months using the Kaplan Meier estimation. In the safety part all the death collected during the study will be reported.

Time frame: At 12 months after inclusion