Radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast.
Trans Tasman Radiation Oncology Group (TROG) 07.01 - A randomised phase III study of radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast to improve time to recurrence
Trans Tasman Radiation Oncology Group Ltd
1,600 participants
Jun 25, 2007
Interventional
Conditions
Summary
Aims - To refine treatment selection for women with non-low risk DCIS to optimise disease control & minimise toxicity - Clinical: To evaluate outcomes after breast conserving surgery by investigating two factors - Addition of tumour bed boost to whole breast RT - Dose fractionation - QoL To compare QoL, psychological distress, perceived risk of invasive disease & perceived cosmetic outcomes amongst treatment arms - Biological: To identify biomarkers/molecular signatures of DCIS predictive of invasive recurrence for therapy individualisation
Eligibility
Inclusion Criteria16
- Women aged >18years.
- 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 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)
- 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.
- 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 Criteria9
- Patients who fulfil 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 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)
- 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: 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.
- 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.
- Women who are pregnant or lactating.
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Interventions
Women will be randomised to receive one of the following four treatments: - Whole breast RT alone using standard fractionation schedule 50 Gy / 25 fractions over 35 days - Whole breast RT alone using shorter fractionation schedule 42.5 Gy / 16 fractions over 22 days - Whole breast RT plus tumour bed boost using standard fractionation schedule - 50 Gy / 25 fractions over 35 days plus 10 Gy / 5 fractions over 5 days - Whole breast RT plus tumour bed boost using shorter fractionation schedule - 42.5 Gy / 16 fractions over 22 days plus 10 Gy / 4 fractions over 4 days
Locations(10)
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ACTRN12607000246482