Status:
UNKNOWN
Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Breast International Group
NCIC Clinical Trials Group
Conditions:
Carcinoma, Ductal, Breast
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Hypotheses: 1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). 2. The r...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
1608 Patients enrolled
Trial Details
Trial ID
NCT00470236
Start Date
June 1 2007
End Date
June 1 2024
Last Update
March 22 2023
Active Locations (120)
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1
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
2
Nepean Cancer Care Centre
Kingswood, New South Wales, Australia
3
St George Hospital
Kogarah, New South Wales, Australia, 2217
4
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170