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

Completed

• Conditions: Squamous Cell Carcinoma of the Anal Canal

• Registration Number: NCT05201105
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Primary Completion: 2021-11-15
• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-21
• Status Verified: 2023-04
• Study Completion: 2023-04-26
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival after abdominal-perineal amputation	Year 2	This outcome corresponds to the number of death.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France