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Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

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ClinicalTrials.gov Identifier: NCT01581840
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : August 3, 2016
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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.

Condition or disease Intervention/treatment Phase
Epidermoid Carcinoma Anus Drug: radiochemotherapy Drug: Panitumumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
Drug Information available for: Panitumumab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Phase I = determination the maximum tolerated dose 5FU and panitumumab in combination with radiotherapy and mitomycin, and thereby to deduce the maximum tolerated dose in patient with localised epidermoid carcinoma of the anus [ Time Frame: 9 weeks after the beginning of treatment ]
    Phase I = determine the dose limiting toxicity of 5FU and panitumumab in combination with radiotherapy and mitomycin, and thereby to deduce the maximum tolerated dose in patient with localised epidermoid carcinoma of the anus

  2. Phase II = Complete response of the tumor rectal examination and morphological exams [ Time Frame: 8 weeks evaluations after the end of the treatment by radiochemotherapy ]
    phase II = Response criteria: complete desappearance of the tumor upon rectal examination and morphological exams (MRI, endoscopic ultrasonography) and non appearance of secondary lesions, response validated by an independant committee.

Secondary Outcome Measures :
  1. Phase II = Partial response rate, stable disease and progression [ Time Frame: 6 weeks and 17 weeks after the beginning of treatment ]
    • Intermediate objective response rate (complete and partial) at 6 weeks (before the additional radiotherapy). The 80% reduction rate in the largest tumour diameter will also be recorded.
    • Partial response rate, stable disease and progression 8 weeks after the end of treatment

  2. Phase II = Colostomy-free survival [ Time Frame: At 3 years after randomization ]
  3. Phase II = Recurrence-free survival at 3 years [ Time Frame: At 3 years after randomization ]
  4. Phase II = Overall survival [ Time Frame: At 3 years after randomization ]
  5. Phase II = Quality of life (EORTC QLQ-C30 + Wexner questionnaire) [ Time Frame: At 3 years after randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581840

Contact: Marie Moreau +33 3 80 39 34 04 marie.moreau@u-bourgogne.fr

Hôpital Avicenne Recruiting
Bobigny, France
Contact: Thomas APARICIO       thomas.aparicio@aphp.fr   
Principal Investigator: Thomas APARICIO         
Institut Radiothérapie Haute Energie Recruiting
Bobigny, France
Contact: Christine LEVY       chrispiedbois@orange.fr   
Principal Investigator: Christine LEVY         
Sub-Investigator: Thomas APARICIO         
Institut Bergonié Recruiting
Bordeaux, France
Contact: Bénédicte HENRIQUES       b.henriques@bordeaux.unicancer.fr   
Principal Investigator: Bénédicte HENRIQUES         
Sub-Investigator: Dominique BECHADE         
Sub-Investigator: Marianne FONCK         
Sub-Investigator: Yves BECOUARN         
Pessac - Hôpital Haut Lévêque Recruiting
Bordeaux, France
Contact: Véronique VENDRELY       veronique.vendrely@chu-bordeaux.fr   
Principal Investigator: Véronique VENDRELY         
Sub-Investigator: Eric TERREBONNE         
Sub-Investigator: Sophie PESQUE         
Sub-Investigator: Julie CHAPUIS         
Hôpital Henri Mondor Recruiting
Creteil, France
Contact: Yazid BELKACEMI       yazid.belkacemi@hmn.aphp.fr   
Principal Investigator: Yazid BELKACEMI         
Sub-Investigator: Elias ASSAF         
Centre d'oncologie et de radiothérapie du Parc Recruiting
Dijon, France
Contact: Arianne DARUT-JOUVE       ariane.jouve@orange.fr   
Principal Investigator: Arianne DARUT-JOUVE         
Sub-Investigator: Marie-Christine BONE-LEPINOY         
Sub-Investigator: Geneviève BOILLOT-JOLIMOY         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Xavier MIRABEL       x-mirabel@o-lambret.fr   
Principal Investigator: Xavier MIRABEL         
Sub-Investigator: Yaovi AMELA         
Sub-Investigator: Farid EL HAJBI         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Christelle DE LA FOURCHARDIERE    04 26 55 67 31      
Principal Investigator: Christelle DE LA FOURCHARDIERE         
Sub-Investigator: Françoise DESSEIGNE         
Hôpital Jean Mermoz Recruiting
Lyon, France
Contact: Gérard LLEDO       glledo@orange.fr   
Principal Investigator: Gérard LLEDO         
Hôpital La Timone Recruiting
Marseille, France
Contact: Laëticia DAHAN       laetitia.dahan@ap-hm.fr   
Principal Investigator: Laëticia DAHAN         
Sub-Investigator: Jean-François SEITZ         
Sub-Investigator: Emmanuelle NORGUET         
Sub-Investigator: Murielle DULUC         
Institut Régional du Cancer Montpellier Recruiting
Montpellier, France
Contact: Claire LEMANSKI       Claire.Lemanski@icm.unicancer.fr   
Principal Investigator: Claire LEMANSKI         
Sub-Investigator: Carmen LLACER MOSCARDO         
Institut de Cancérologie de Lorraine Recruiting
Nancy, France
Contact: Didier PEIFFERT       d.peiffert@nancy.unicancer.fr   
Principal Investigator: Didier PEIFFERT         
Sub-Investigator: Thierry CONROY         
Sub-Investigator: Marie Christine KAMINSKY         
Sub-Investigator: Anne Sophie BAUMANN         
Sub-Investigator: Anne Agathe SERRE         
Hôpital Saint Louis Recruiting
Paris, France
Contact: Laurent QUERO       laurent.quero@sls.aphp.fr   
Principal Investigator: Laurent QUERO         
Institut Curie Recruiting
Paris, France
Contact: Anne DE LA ROCHEFORDIERE       anne.de-la-rochefordiere@curie.fr   
Principal Investigator: Anne DE LA ROCHEFORDIERE         
Sub-Investigator: Christophe LE TOURNEAU         
Sub-Investigator: Marie-Paule SABLIN         
Sub-Investigator: Simona POP         
Sub-Investigator: Véronique DIERAS         
Cario - HPCA - Hôpital privé des Côtes D'Armor Recruiting
Plérin, France
Contact: Pierre-Luc ETIENNE       pl.etienne@cario-sante.fr ; pl.etienne@wanadoo.fr   
Principal Investigator: Pierre-Luc ETIENNE         
Sub-Investigator: Dominique BESSON         
Sub-Investigator: Anne-Claire HARDY-BESSARD         
Centre Eugène Marquis Recruiting
Rennes, France
Contact: Astrid LIEVRE       astrid.lievre@chu-rennes.fr   
Principal Investigator: Astrid LIEVRE         
Sub-Investigator: Christophe PERRIN         
Sub-Investigator: Julien EDELINE         
Sub-Investigator: Marie TALARMIN         
Sub-Investigator: Thierry LESIMPLE         
Hôpital du Pontchaillou Recruiting
Rennes, France
Contact: Astrid LIEVRE       astrid.lievre@chu-rennes.fr   
Principal Investigator: Astrid LIEVRE         
Institut Curie Recruiting
Saint Cloud, France
Contact: Marion RICHARD-MOLARD       marion.richard-molard@curie.fr   
Principal Investigator: Marion RICHARD-MOLARD         
Sub-Investigator: Barbara DIEUMEGARD         
Hôpital Foch Recruiting
Suresnes, France
Contact: May MABRO       m.mabro@hopital-foch.org   
Principal Investigator: May MABRO         
Hôpital Trousseau Recruiting
Tours, France
Contact: Thierry LECOMTE       thierry.lecomte@med.univ-tours.fr   
Principal Investigator: Thierry LECOMTE         
Hôpitaux Bretonneau Recruiting
Tours, France
Contact: Sophie CHAPET       s.chapet@chu-tours.fr   
Principal Investigator: Sophie CHAPET         
Sub-Investigator: Thierry LECOMTE         
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Principal Investigator: Véronique VENDRELY, MD Hôpital Haut-Lévêque - Bordeaux

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT01581840     History of Changes
Other Study ID Numbers: FFCD 0904
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:

Additional relevant MeSH terms:
Anus Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Neoplasms, Squamous Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs