Suspended

IMRT-FULong Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

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What is being tested

Adjuvant breast radiotherapy

+ Adjuvant breast radiotherapy

Device
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 20 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorSunnybrook Health Sciences Centre
Study ContactJean-Philippe Pignol, MD, PhDMore contacts
Last updated: March 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

In 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast IMRT. The study showed a significant reduction moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of breast IMRT compared to standard radiotherapy. The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. The investigators also hypothesize that there will not be differences in the local control rate or survival.

NCT01803139
Principal SponsorSunnybrook Health Sciences Centre
Study ContactJean-Philippe Pignol, MD, PhDMore contacts
Last updated: March 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

358 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

1 inclusion criteria required to participate
Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial
3 exclusion criteria prevent from participating
Patients deceased
Patients declining participating to this study
Patients unable to travel to the study site

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.

Group II

Experimental
The treatment is planned 3D IMRT optimisation using all CT-planning slices.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Vancouver Island Cancer Centre

Victoria, CanadaOpen Vancouver Island Cancer Centre in Google Maps

Sunnybrook Odette Cancer Centre

Toronto, Canada
Suspended2 Study Centers