Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

Launched by TRANS TASMAN RADIATION ONCOLOGY GROUP · May 4, 2007

Keywords

ClinConnect Summary

Specific objectives:

1. To evaluate time to local recurrence in women with DCIS treated with breast conserving surgery followed by:

* whole breast RT alone versus whole breast RT plus tumour bed boost;
* RT using the standard fractionation schedule versus the shorter schedule.
2. To evaluate time to disease recurrence and overall survival in women with DCIS treated with breast conserving surgery followed by:

* whole breast RT alone versus whole breast RT plus tumour bed boost;
* RT using the standard fractionation schedule versus the shorter schedule.
3. To compare the toxici...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Patients must fulfill all of the following criteria for admission to study:
• • Women ≥ 18 years.
• • Histologically proven DCIS of the breast without an invasive component.
• • Bilateral mammograms performed within 6 months prior to randomization.
• • 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.
• Exclusion Criteria:
• Patients who fulfill any of the following criteria are not eligible for admission to study:
• • 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.
• • Bilateral DCIS of the breasts
• • Synchronous invasive carcinoma 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.