NCT03465501

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2007

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

9 years

First QC Date

March 5, 2018

Last Update Submit

March 13, 2018

Conditions

Keywords

Anal Canal Cancerbrachytherapy

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the efficacy of interstitial brachytherapy of the anal canal

    Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate

    1 year

  • 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 Outcomes (4)

  • Estimation of local control

    1 year

  • Estimation of disease free survival

    1 year

  • Estimation of overall survival

    1 year

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

    1 year

Study Arms (2)

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

BrachytherapyRADIATION

Brachytherapy

High Dose RateLow Dose Rate

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients treated by brachytherapy anal canal to boost.

You may not qualify if:

  • Patients below age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Anal Canal Carcinoma

Interventions

Brachytherapy

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Leonel VARELA GAGETTI

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 14, 2018

Study Start

August 17, 2007

Primary Completion

July 28, 2016

Study Completion

July 28, 2016

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations