A randomised Phase III study of radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast
- Conditions
- Ductal Carcinoma in Situ10006291
- Registration Number
- NL-OMON38251
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
- Women with completely excised non-low risk DCIS of the breast treated by breast conserving surgery may be admitted to the study. Clinicians may enter patients onto the study, guided by individual equipoise, within the eligibility requirements of the study. ;- Women aged >=18 years ;- Histologically proven DCIS of the breast without an invasive component. ;- Bilateral mammograms performed within 6 months prior to randomisation. ;- Clinically node-negative. ;- Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of 1 mm*.
*Patients with superficial or deep resection margin of < 1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.;- Women who are at high risk of local recurrence due to: ;- Age < 50 years; OR
- Age 50 years plus at least one of the following:
Symptomatic presentation
Palpable tumour
Multifocal disease
Microscopic tumour size >= 1.5 cm in maximum dimension
Intermediate or high nuclear grade
Central necrosis
Comedo histology
Radial* surgical resection margin < 10 mm
*Patients with superficial or deep resection margin of < 10 mm are eligible if surgery has not removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia. ;- Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT. ;- Ability to tolerate protocol treatment. ;- Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure. ;- ECOG performance status 0, 1 or 2. ;- Patient*s life expectancy > 5 years. ;- Availability for long-term follow-up. ;- Written informed consent.
- Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of 1 mm*.
*Patients with superficial and/or deep margin of < 1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
- Presence of tumour cells in lymph nodes detected using H & E or immunohistochemical examination (if lymph node biopsy or dissection has been performed). ;- Locally recurrent breast cancer. ;- Previous DCIS or invasive cancer of the contralateral breast. ;- Other concurrent or previous malignancies except: Non-melanomatous skin cancer; Carcinoma in situ of the cervix or endometrium; and Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence. ;- Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease). ;- ECOG performance status >=3. ;- Women who are pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to local recurrence </p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival<br /><br>Time to disease recurrence<br /><br>Cosmetic outcome<br /><br>Toxicity<br /><br>Quality of life </p><br>