Clinical trial · Interventional
Long Term Results of the Canadian Breast IMRT Study
Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant breast radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard breast radiotherapy
- description
- The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
- interventionNames
- Device: Adjuvant breast radiotherapy
- type
- EXPERIMENTAL
- label
- Breast IMRT
- description
- The treatment is planned 3D IMRT optimisation using all CT-planning slices.
- interventionNames
- Device: Adjuvant breast radiotherapy
Primary outcomes (4)
- measure
- Chronic breast pain using Visual Analog Scale
- timeFrame
- 8 years plus or minus one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19. PMID 18285602