Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus (RTA)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph
Squamous cell carcinoma of the anal canal is a rare cancer with an increasing incidence. It represents 2.5% of digestive cancers and occurs more frequently in immunocompromised persons, in particular HIV positive. It is a cancer that develops essentially locally, with only 5% of metastases at diagnosis. The reference treatment for forms deemed localized after clinico-bio-radiological pre-therapeutic evaluation is radiochemotherapy allowing a 5-year survival rate of about 80%. However, up to 30% of patients fail radiochemotherapy. Failure is defined as persistent disease (non response or progression in 10 to 15% of patients) or relapse (local or metastatic in 10 to 15% of patients). Salvage surgery by abdominoperineal amputation is indicated in this case after elimination of the metastatic character with an overall survival rate at 5 years varying from 23 to 69%. This complex and cumbersome surgery is burdened with significant postoperative morbidity with alteration of the quality of life. Investigators would like to perform a retrospective and prospective study in the Paris Saint-Joseph hospital group to evaluate the interest of abdominoperineal amputation in case of failure of radiochemotherapy in patients with squamous cell carcinoma of the anal canal.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

43

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
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

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

Sampling Method

Non-Probability Sample

Study Population

These patients were referred for squamous cell carcinoma of the anus for abdominoperineal amputation between 09/03/2010 and 05/01/2021.

Description

Inclusion Criteria:

  • Patient with abdominoperineal amputation for squamous cell carcinoma of the anus
  • Patient whose age ≥ 18 years
  • French speaking patient

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival after abdominal-perineal amputation in case of failure of radiochemotherapy
Time Frame: Week 26
This outcome corresponds to the Recurrence-free survival (local, metastatic) after abdominal and perineal amputation in case of failure of radio chemotherapy.
Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after abdominal-perineal amputation
Time Frame: Year 2
This outcome corresponds to the number of death.
Year 2

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Sandr GRANIER, MD, Groupe Hospitalier Paris Saint Joseph

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)

October 15, 2021

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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