Clinical trial NCT01537406: Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy
Official title: Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-02-23
Enrollment: 314
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer subjects treated in Toronto, Ontario, or in Victoria, British Columbia that participated in The Canadian breast IMRT clinical trial between July 2003 to March 2005.

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.

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.

Primary outcomes:
measure: Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.
timeFrame: 8 years post RT
Secondary outcomes:
measure: Does breast IMRT reduce the occurrence of late radiation therapy side effects
timeFrame: 8 years post RT
measure: Does breast IMRT effect long term QOL
timeFrame: 8 Years post RT
measure: Does IMRT effect local recurrence rates, overall and disease free survivals.
timeFrame: 8 years post RT
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: BCCA - Vancouver Island Cancer Centre
state: British Columbia
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Odette Cancer Centre
name: Jean-Philippe Pignol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BCCA - Vancouver Island Cancer Centre
name: Pauline Truong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BCCA - Vancouver Island Cancer Centre
name: Ivo Olivotto, MD
role: PRINCIPAL_INVESTIGATOR
References: