CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT05201105
NCT05201105N/ACompleted

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

Fondation Hôpital Saint-Joseph·observational·Posted Jan 21, 2022·Updated Apr 27, 2023

In Brief

An observational study for Squamous Cell Carcinoma of the Anal Canal. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 21, 2022
Enrollment StartOct 15, 2021
Primary CompletionNov 15, 2021
Study CompletionApr 26, 2023
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.4 years ago