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

Anal Canal Cancer Clinical Trial

— BOOST-CA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465501
• Other study ID #: BOOST-CA IPC 2017-016
• Status: Completed
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 13, 2018
• Start date: August 17, 2007
• Est. completion date: July 28, 2016

Study information

• Verified date: March 2018
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 28, 2016
• Est. primary completion date: July 28, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated by brachytherapy anal canal to boost.

Exclusion Criteria:

• Patients below age of 18 years

Related Conditions & MeSH terms

• Anal Canal Cancer
• Anus Neoplasms

Intervention

Radiation:
• Brachytherapy
Brachytherapy

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (2)

Boukhelif W, Ferri-Molina M, Mazeron R, Maroun P, Duhamel-Oberlander AS, Dumas I, Martinetti F, Guemnie-Tafo A, Chargari C, Haie-Meder C. Interstitial pulsed-dose-rate brachytherapy for the treatment of squamous cell anal carcinoma: A retrospective single — View Citation

Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequéant B, Lartigau E. Low-dose-rate interstitial brachytherapy boost for the treatment of anal canal cancers. Brachytherapy. 2017 Jan - Feb;16(1):230-235. doi: 10.1016/j.brachy.2016.07.007. Epub 2016 Sep 3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of interstitial brachytherapy of the anal canal	Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate	1 year
Primary	Evaluation of the tolerance of interstitial brachytherapy of the anal canal	Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.	1 year
Secondary	Estimation of local control	Local control defined as the time between the date of diagnosis and the date of local relapse or death or recent news	1 year
Secondary	Estimation of disease free survival	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	1 year
Secondary	Estimation of overall survival	Overall survival defined as the time between the date of diagnosis and the date of death or latest news	1 year
Secondary	Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups	rate of toxicities	1 year