Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

June 27, 2024 updated by: Federation Francophone de Cancerologie Digestive

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Pessac - Hôpital Haut Lévêque
      • Colmar, France
        • Ch - Hopitaux Civils de Colmar
      • Dijon, France
        • Centre d'Oncologie et de Radiothérapie du Parc
      • Lille, France
        • Centre Oscar Lambret
      • Lorient, France
        • CH - CHBS - Hôpital du Scorff
      • Lyon, France
        • Centre Léon Bérard
      • Montpellier, France
        • Institut régional du Cancer Montpellier
      • Mougins, France
        • Clinique Privée - Plein Ciel
      • Paris, France
        • Institut Curie
      • Plérin, France
        • Cario - HPCA - Hôpital privé des Côtes D'Armor
      • Pringy, France
        • CH - Annecy Genevois
      • Rennes, France
        • Centre Eugène Marquis
      • Saint Cloud, France
        • Institut Curie
      • Saint Priest en Jarez, France
        • CHU
      • Strasbourg, France
        • CAC - Paul Strauss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Complete Response to Treatment
Time Frame: 8 weeks evaluations after the end of the treatment by radiochemotherapy

Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee:

  • In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used;
  • in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint
8 weeks evaluations after the end of the treatment by radiochemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Complete Response to Treatment
Time Frame: 16 weeks after the end of the treatement by radiotherapy
Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance according to the investigator's opinion
16 weeks after the end of the treatement by radiotherapy
3 Years Colostomy-free Survival (CFS)
Time Frame: At 3 years after inclusion
It was defined as the time from inclusion to the date of colostomy or death (from any cause). Patients alive without colostomy were censored at date of last news. If a patient had a shunt colostomy and continuity wasrestored, the patient was counted among the patients without a colostomy.
At 3 years after inclusion
Recurrence-free Survival (RFS) at 3 Years
Time Frame: At 3 years after inclusion
It was defined as the time from inclusion to the date of first recurrence (local, regional, metastatic and second anal cancer) or death. Patients alive without recurrence were censored at date of last news.
At 3 years after inclusion
Overall Survival (OS) at 12 Months
Time Frame: At 12 months after inclusion

The percentage was evaluated at 12 months using the Kaplan Meier estimation.

In the safety part all the death collected during the study will be reported.
At 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Véronique VENDRELY, MD, Hôpital Haut-Lévêque - Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimated)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFCD 0904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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