Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates

Completed

• Conditions: Anal Canal Cancer
• Interventions: Radiation: Brachytherapy

• Registration Number: NCT03465501
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting \[low dose rate (LDR) and high dose rate (HDR)\]

Detailed Description

Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.

Study Timeline

• Study Start: 2007-08-17
• Primary Completion: 2016-07-28
• Study Completion: 2016-07-28
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-13
• Study First Posted: 2018-03-14
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Patients treated by brachytherapy anal canal to boost.

Exclusion Criteria

• Patients below age of 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Dose Rate	Brachytherapy	Patients treated by brachytherapy with a high dose rate of the anal canal aiming for boost
Low Dose Rate	Brachytherapy	Patients treated with brachytherapy at low dose rate of the anal canal with aim of boost

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of interstitial brachytherapy of the anal canal	1 year	Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate
Evaluation of the tolerance of interstitial brachytherapy of the anal canal	1 year	Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.

Secondary Outcome Measures

Name	Time	Method
Estimation of local control	1 year	Local control defined as the time between the date of diagnosis and the date of local relapse or death or recent news
Estimation of disease free survival	1 year	Disease free survival defined as the delay between the date of diagnosis and the date of local or locoregional or distant relapse or death or recent news
Estimation of overall survival	1 year	Overall survival defined as the time between the date of diagnosis and the date of death or latest news
Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups	1 year	rate of toxicities

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France