Clinical trial NCT01581840: Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus
Official title: Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Epidermoid Carcinoma
Anus
Keywords: anus
carcinoma
panitumumab
mitomycine
5Fu
radiotherapy
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Complete Response to Treatment
timeFrame: 8 weeks evaluations after the end of the treatment by radiochemotherapy
Secondary outcomes:
measure: Percentage of Patients With Complete Response to Treatment
timeFrame: 16 weeks after the end of the treatement by radiotherapy
measure: 3 Years Colostomy-free Survival (CFS)
timeFrame: At 3 years after inclusion
measure: Recurrence-free Survival (RFS) at 3 Years
timeFrame: At 3 years after inclusion
measure: Overall Survival (OS) at 12 Months
timeFrame: At 12 months after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pessac - Hôpital Haut Lévêque
city: Colmar
country: France
facility: CH - Hopitaux civils de Colmar
city: Dijon
country: France
facility: Centre d'oncologie et de radiothérapie du Parc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: CH - CHBS - Hôpital du Scorff
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Institut Régional du Cancer Montpellier
city: Mougins
country: France
facility: Clinique Privée - Plein Ciel
city: Paris
country: France
facility: Institut Curie
city: Plérin
country: France
facility: Cario - HPCA - Hôpital privé des Côtes D'Armor
city: Pringy
country: France
facility: CH - Annecy Genevois
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint Cloud
country: France
facility: Institut Curie
city: Saint Priest en Jarez
country: France
facility: CHU
city: Strasbourg
country: France
facility: CAC - Paul Strauss
Study officials:
affiliation: Hôpital Haut-Lévêque - Bordeaux
name: Véronique VENDRELY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vendrely V, Lemanski C, Gnep K, Barbier E, Hajbi FE, Lledo G, Dahan L, Terrebonne E, Manfredi S, Mirabel X, Mammar V, Cowen D, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904). Radiother Oncol. 2019 Nov;140:84-89. doi: 10.1016/j.radonc.2019.05.018. Epub 2019 Jun 8.