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CompletedNCT03465501BOOST-CAUpdated Mar 14, 2018

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

An observational study in Anal Canal Cancer, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Institut Paoli-Calmettes · Observational

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Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
89
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Anal Canal Cancer

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Keywords

  • Anal Canal Cancer
  • brachytherapy
03

In context

Anal Canal Carcinoma

33 studies on the registry are indexed under Anal Canal Carcinoma; 8 are open to participants now.

Browse Anal Canal Carcinoma studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients treated by brachytherapy anal canal to boost.

Exclusion criteria

Exclusion Criteria:

  • Patients below age of 18 years
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
89 participants (actual)
Patient registry
No

Groups and cohorts

  • Low Dose Rate

    Patients treated with brachytherapy at low dose rate of the anal canal with aim of boost

    Radiation: Brachytherapy

  • High Dose Rate

    Patients treated by brachytherapy with a high dose rate of the anal canal aiming for boost

    Radiation: Brachytherapy

Interventions

  • RadiationBrachytherapy

    Brachytherapy

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What researchers measure

Primary outcomes

  1. Evaluation of the efficacy of interstitial brachytherapy of the anal canal

    Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. Estimation of overall survival

    Overall survival defined as the time between the date of diagnosis and the date of death or latest news

    Time frame: 1 year

  4. Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups

    rate of toxicities

    Time frame: 1 year

07

Study locations

1 site
  • Institut Paoli Calmettes
    Marseille, Bouches Du Rhone 13009, France
08

References and documents

Publications

  • Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequeant 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. PubMed 27600606 ↗
  • 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 institution analysis. Brachytherapy. 2015 Jul-Aug;14(4):549-53. doi: 10.1016/j.brachy.2015.03.006. Epub 2015 Apr 29. PubMed 25935731 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2007 to primary completion in Jul 2016, 107 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 14, 2018
StartActual
Aug 17, 2007
Primary completionActual
Jul 28, 2016
CompletionActual
Jul 28, 2016
Last update
Mar 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03465501
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Aug 17, 2007
Primary completion
Jul 28, 2016
Completion
Jul 28, 2016
Last update
Mar 14, 2018

Study contacts

Leonel VARELA GAGETTI
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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