Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus
NCT ID: NCT01581840
Last Updated: 2024-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2016-01-31
2021-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Véronique VENDRELY, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Haut-Lévêque - Bordeaux
Locations
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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, , France
Countries
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References
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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.
Vendrely V, Ronchin P, Minsat M, Le Malicot K, Lemanski C, Mirabel X, Etienne PL, Lievre A, Darut-Jouve A, de la Fouchardiere C, Giraud N, Breysacher G, Argo-Leignel D, Thimonnier E, Magne N, Abdelghani MB, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Panitumumab in combination with chemoradiotherapy for the treatment of locally-advanced anal canal carcinoma: Results of the FFCD 0904 phase II trial. Radiother Oncol. 2023 Sep;186:109742. doi: 10.1016/j.radonc.2023.109742. Epub 2023 Jun 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FFCD 0904
Identifier Type: -
Identifier Source: org_study_id
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