Radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast.

Phase 3

Active, not recruiting

• Conditions: Completely excised non-low risk DCIS; Cancer - Breast

• Registration Number: ACTRN12607000246482
• Lead Sponsor: Trans Tasman Radiation Oncology Group Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-08
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 1608

Inclusion Criteria

1. Women aged >18years.
2. Histologically proven DCIS of the breast without an invasive component.
3. Bilateral mammograms performed within 6 months prior to randomisation.
3. Clinically node-negative.
4. Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of greater than or equal to 1mm (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)
5. 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: a) Symptomatic presentation
b) Palpable tumour c) Multifocal disease
d) Microscopic tumour size = 1.5 cm in maximum dimension e) Intermediate or high nuclear grade f) Central necrosis
g) Comedo histology h) 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.
6. Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT.
7. Ability to tolerate protocol treatment.
8. Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure
9. ECOG performance status 0, 1 or 2.
10. Patient’s life expectancy > 5 years
11. Availability for long-term follow-up.
12. Written informed consent.

Exclusion Criteria

Patients who fulfil any of the following criteria are not eligible for admission to study:-
1. Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of greater than or equal to 1mm (Patients with superficial and/or deep margin of < 1mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia)
2. Presence of tumour cells in lymph nodes detected using H&E or immunohistochemical examination (if lymph node biopsy or dissection has been performed).
3. Locally recurrent breast cancer.
4. Previous DCIS or invasive cancer of the contralateral breast.
5. Other concurrent or previous malignancies except: a) Non-melanomatous skin cancer; b) Carcinoma in situ of the cervix or endometrium; and
c) Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence.
6. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).- 7. ECOG performance status = 3.
8. Women who are pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified