Clinical trial · Interventional
A Clinical Trial to Reduce Skin Burn Induced by Breast Radiotherapy Using Intensity Modulated Radiation Therapy (IMRT)
A Phase III Study of Adjuvant Radiation Therapy in Early Breast Cancer Comparing the Use of Breast Intensity Modulated Radiation Therapy (IMRT) to Conventional Wedge Technique
NCT00187343CI-TRIAL-00001671completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether the use of a 3D missing tissue compensation radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy in 25 treatments could reduce significantly the occurence rate and the degree of acute skin reaction compared to a standard wedged irradiation technique.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast IMRT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum skin toxicity measured weekly during the tratment and bi-weekly up to one month after the end of the treatment and complete resolution of skin reaction using the NCI common toxicity criteria version 3.0 scale
Secondary outcomes (7)
- measure
- Breast localisation of maximum acute skin toxicity;
- measure
- Time of onset of acute skin toxicity;
- measure
- Pain assessment;
- measure
- Duration of symptoms;
- measure
- Factors associated with acute skin reactions;
- measure
- HRQOL;
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * A confirmed histological diagnosis of breast carcinoma or DCIS; * Treated by breast conserving surgery; * Adjuvant radiation to the breast only (less than 3 positive lymph nodes); * Having a ECOG performance status of 0 or 1. * Having signed an informed consent. Exclusion Criteria: * Patients treated by mastectomy; * Bilateral breast cancer; * Having an unhealed surgical scar (skin not closed and/or infection); * Having had prior radiation to the same breast; * Having active connective tissue disorder; * Patient being pregnant.
References
Publications (1)
- BACKGROUNDMihai A, Rakovitch E, Sixel K, Woo T, Cardoso M, Bell C, Ruschin M, Pignol JP. Inverse vs. forward breast IMRT planning. Med Dosim. 2005 Fall;30(3):149-54. doi: 10.1016/j.meddos.2005.03.004. PMID 16112466