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Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Primary Purpose

Epidermoid Carcinoma, Anus

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
radiochemotherapy
Panitumumab
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermoid Carcinoma focused on measuring anus, carcinoma, panitumumab, mitomycine, 5Fu, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pessac - Hôpital Haut Lévêque
  • CH - Hopitaux civils de Colmar
  • Centre d'oncologie et de radiothérapie du Parc
  • Centre Oscar Lambret
  • CH - CHBS - Hôpital du Scorff
  • Centre Léon Bérard
  • Institut Régional du Cancer Montpellier
  • Clinique Privée - Plein Ciel
  • Institut Curie
  • Cario - HPCA - Hôpital privé des Côtes D'Armor
  • CH - Annecy Genevois
  • Centre Eugène Marquis
  • Institut Curie
  • CHU
  • CAC - Paul Strauss

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

5Fu-mitomycine-panitumumab + radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Response to treatment

Secondary Outcome Measures

Partial response rate, stable disease and progression
Colostomy-free survival
Recurrence-free survival at 3 years
Overall survival

Full Information

First Posted
April 6, 2012
Last Updated
March 23, 2022
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT01581840
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermoid Carcinoma, Anus
Keywords
anus, carcinoma, panitumumab, mitomycine, 5Fu, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5Fu-mitomycine-panitumumab + radiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
radiochemotherapy
Intervention Description
Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Intervention Description
3 or 6 mg/kg (according to dose level)
Primary Outcome Measure Information:
Title
Response to treatment
Time Frame
8 weeks evaluations after the end of the treatment by radiochemotherapy
Secondary Outcome Measure Information:
Title
Partial response rate, stable disease and progression
Time Frame
6 weeks and 17 weeks after the beginning of treatment
Title
Colostomy-free survival
Time Frame
At 3 years after randomization
Title
Recurrence-free survival at 3 years
Time Frame
At 3 years after randomization
Title
Overall survival
Time Frame
At 3 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique VENDRELY, MD
Organizational Affiliation
Hôpital Haut-Lévêque - Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pessac - Hôpital Haut Lévêque
City
Bordeaux
Country
France
Facility Name
CH - Hopitaux civils de Colmar
City
Colmar
Country
France
Facility Name
Centre d'oncologie et de radiothérapie du Parc
City
Dijon
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
CH - CHBS - Hôpital du Scorff
City
Lorient
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Régional du Cancer Montpellier
City
Montpellier
Country
France
Facility Name
Clinique Privée - Plein Ciel
City
Mougins
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Cario - HPCA - Hôpital privé des Côtes D'Armor
City
Plérin
Country
France
Facility Name
CH - Annecy Genevois
City
Pringy
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Institut Curie
City
Saint Cloud
Country
France
Facility Name
CHU
City
Saint Priest en Jarez
Country
France
Facility Name
CAC - Paul Strauss
City
Strasbourg
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31185328
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.
Results Reference
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Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

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