Clinical Trials Directory

Trials / Completed

CompletedNCT05201105

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

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
Fondation Hôpital Saint-Joseph · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2021-10-15
Primary completion
2021-11-15
Completion
2023-04-26
First posted
2022-01-21
Last updated
2023-04-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05201105. Inclusion in this directory is not an endorsement.