Clinical trial NCT05201105: Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus
Official title: Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma of the Anal Canal
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence-free survival after abdominal-perineal amputation in case of failure of radiochemotherapy
timeFrame: Week 26
Secondary outcomes:
measure: Overall survival after abdominal-perineal amputation
timeFrame: Year 2
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Sandr GRANIER, MD
role: PRINCIPAL_INVESTIGATOR
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