Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy

NCT01537406 | Unknown DMC

• 1 other identifier: BCCABreastIMRT
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Does breast IMRT reduce the occurrence of late radiation therapy side effects

  8 years post RT

• Does breast IMRT effect long term QOL

  8 Years post RT

• Does IMRT effect local recurrence rates, overall and disease free survivals.

  8 years post RT

Interventions

BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R6V5, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Philippe Pignol, MD

  Odette Cancer Centre

  PRINCIPAL INVESTIGATOR

• Pauline Truong, MD

  BCCA - Vancouver Island Cancer Centre

  PRINCIPAL INVESTIGATOR

• Ivo Olivotto, MD

  BCCA - Vancouver Island Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 23, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

CA (2)