Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy

NCT ID: NCT01537406

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 314 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.

Detailed Description

The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".

The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY

LONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study

Exclusion Criteria

• Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Pignol, MD

Role: PRINCIPAL_INVESTIGATOR

Odette Cancer Centre

Pauline Truong, MD

Role: PRINCIPAL_INVESTIGATOR

BCCA - Vancouver Island Cancer Centre

Ivo Olivotto, MD

Role: PRINCIPAL_INVESTIGATOR

BCCA - Vancouver Island Cancer Centre

Locations

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

BCCABreastIMRT

Identifier Type: -

Identifier Source: org_study_id