CompletedPhase 3

A Clinical Trial to Reduce Skin Burn Induced by Breast Radiotherapy Using Intensity Modulated Radiation Therapy (IMRT)

Canada340 participantsStarted 2003-09

Plain-language summary

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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT00187343

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

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