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Long Term Results of the Canadian Breast IMRT Study (IMRT-FU)

S

Sunnybrook Health Sciences Centre

Status and phase

Unknown
Phase 3

Conditions

Breast Cancer

Treatments

Device: Adjuvant breast radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01803139
IMRT-02

Details and patient eligibility

About

Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.

Full description

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.

Enrollment

358 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial

Exclusion criteria

  • Patients declining participating to this study
  • Patients unable to travel to the study site
  • Patients deceased

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

358 participants in 2 patient groups

Standard breast radiotherapy
Active Comparator group
Description:
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
Treatment:
Device: Adjuvant breast radiotherapy
Breast IMRT
Experimental group
Description:
The treatment is planned 3D IMRT optimisation using all CT-planning slices.
Treatment:
Device: Adjuvant breast radiotherapy

Trial contacts and locations

2

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Central trial contact

Pauline Truong, MD, MSc; Jean-Philippe Pignol, MD, PhD

Data sourced from clinicaltrials.gov

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