Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Epidermoid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581840
• Other study ID #: FFCD 0904
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2012
• Est. completion date: February 2021

Study information

• Verified date: March 2022
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2021
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anus
• Anus Neoplasms
• Carcinoma
• Carcinoma, Squamous Cell
• Epidermoid Carcinoma

Intervention

Drug:
• radiochemotherapy
Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²
• Panitumumab
3 or 6 mg/kg (according to dose level)

Locations

Country	Name	City	State
France	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	CH - Annecy Genevois	Pringy
France	Centre Eugène Marquis	Rennes
France	Institut Curie	Saint Cloud
France	CHU	Saint Priest en Jarez
France	CAC - Paul Strauss	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (1)

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 ch — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment		8 weeks evaluations after the end of the treatment by radiochemotherapy
Secondary	Partial response rate, stable disease and progression		6 weeks and 17 weeks after the beginning of treatment
Secondary	Colostomy-free survival		At 3 years after randomization
Secondary	Recurrence-free survival at 3 years		At 3 years after randomization
Secondary	Overall survival		At 3 years after randomization