Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates (BOOST-CA)

March 13, 2018 updated by: Institut Paoli-Calmettes
Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with anal canal brachytherapy for boost, between 2008 and 2016.

Description

Inclusion Criteria:

  • Patients treated by brachytherapy anal canal to boost.

Exclusion Criteria:

  • Patients below age of 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of interstitial brachytherapy of the anal canal
Time Frame: 1 year
Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate
1 year
Evaluation of the tolerance of interstitial brachytherapy of the anal canal
Time Frame: 1 year
Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of local control
Time Frame: 1 year
Local control defined as the time between the date of diagnosis and the date of local relapse or death or recent news
1 year
Estimation of disease free survival
Time Frame: 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
1 year
Estimation of overall survival
Time Frame: 1 year
Overall survival defined as the time between the date of diagnosis and the date of death or latest news
1 year
Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups
Time Frame: 1 year
rate of toxicities
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Leonel VARELA GAGETTI, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2007

Primary Completion (Actual)

July 28, 2016

Study Completion (Actual)

July 28, 2016

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOOST-CA IPC 2017-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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