To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. To individualise treatment selection for women with DCIS to achieve long term disease control with minimal toxicity
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to local recurrence
Secondary outcome
Overall survival
Time to disease recurrence
Cosmetic outcome
Toxicity
Quality of life
Background summary
Since the introduction of mammographic screening for breast cancer, there has
been a significant increase in the diagnosis of ductal carcinoma in situ
(DCIS). The clinical approach to DCIS is predicated by experience with invasive
breast cancer. This prospective randomised trial addresses an urgent clinical
need to provide information for an evidence-based practice in the
individualised management of women with DCIS. This will not only inform a
consistent policy in the use of radiotherapy (RT) for DCIS but also have the
potential to streamline the use of RT services. In addition, the psychological
impact and quality of life consequences of the diagnosis and treatment of women
with DCIS are poorly understood. The study will provide high quality research
that is vital to the provision of appropriate psychosocial support for these
women. The study will also form the basis for investigation of the essential
biological nature of DCIS and identification of predictive biomarkers of
treatment failure or toxicity that may provide useful clinical indicators in
the future.
Study objective
To improve the outcome of women with non-low risk DCIS treated with breast
conserving therapy.
To individualise treatment selection for women with DCIS to achieve long term
disease control with minimal toxicity
Study design
A multi-centre, non-blinded, phase III randomised trial.
Intervention
Randomisation B:
Arm 1: Whole breast RT alone: standard WB fractionation; 50 Gy/25 fractions/35
days
Arm 3: Whole breast RT standard WB fractionation plus tumour bed boost; 50
Gy/25 fractions/35 days
Boost 16 Gy/8 fractions/10 days
Randomisation C:
Arm 2: Whole breast RT alone shorter WB fractionation; 42.5 Gy/16 fractions/22
days
Arm 4: Whole breast RT, shorter WB fractionation plus tumour bed boost; 42.5
Gy/16 fractions/22 days
Boost 16 Gy/8 fractions/10 days
Study burden and risks
Quality of Life and cosmetic evaluation.
Avenue E.Mounier 83, bte 11
BE 1200 BRUSSELS
BE
Avenue E.Mounier 83, bte 11
BE 1200 BRUSSELS
BE
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00470236 |
| CCMO | NL28754.091.09 |