Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy

Breast Cancer Clinical Trial

— BIMRT  

Official title:

Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01537406
• Other study ID #: BCCABreastIMRT
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 15, 2012
• Last updated: March 7, 2012
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2012
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada:UBC BCCA Research Ethics Board.
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 314
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	BCCA - Vancouver Island Cancer Centre	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.	A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire	8 years post RT	No
Secondary	Does breast IMRT reduce the occurrence of late radiation therapy side effects	A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.; Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire	8 years post RT	No
Secondary	Does breast IMRT effect long term QOL	A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.; Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire	8 Years post RT	No
Secondary	Does IMRT effect local recurrence rates, overall and disease free survivals.	Data collection of local recurrences, overall and disease free survivals.	8 years post RT	No