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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05201105

Acronym

RTA

Enrollment

Registered

2022-01-21

Start date

2021-10-15

Completion date

2023-04-26

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of the Anal Canal

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results