Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
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Hypotheses:
- 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).
- The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
- A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.
Overall Objectives:
- To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
- To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Ductal, Breast |
Radiation: Whole breast radiation therapy alone - Standard schedule Radiation: Whole breast radiation therapy alone - Shorter schedule Radiation: Whole breast RT plus tumour bed boost - Standard schedule Radiation: Whole breast RT plus tumour bed boost - Shorter schedule |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast |
- Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence. [ Time Frame: Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Measured from the date of randomization to the date of death from any cause. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ] [ Designated as safety issue: No ]
- Time to disease recurrence [ Time Frame: Measured from the date of randomization to the date of first evidence of recurrent disease. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ] [ Designated as safety issue: No ]
- Cosmetic Outcome [ Time Frame: Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT. ] [ Designated as safety issue: No ]
- Radiation toxicity [ Time Frame: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10. ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT. ] [ Designated as safety issue: No ]
Estimated Enrollment: | 1600 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | November 2025 |
Estimated Primary Completion Date: | November 2022 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
Whole Breast RT alone - Standard fractionation schedule
|
Radiation: Whole breast radiation therapy alone - Standard schedule
A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
Other Name: Radiation
|
Experimental: 2
Whole Breast RT alone - Shorter fractionation schedule
|
Radiation: Whole breast radiation therapy alone - Shorter schedule
A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
Other Name: Radiation
|
Active Comparator: 3
Whole Breast RT + tumor bed boost - Standard fractionation schedule
|
Radiation: Whole breast RT plus tumour bed boost - Standard schedule
Whole Breast: A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight). Tumour bed: A total dose of 10 Gy in 5 fractions in 2-Gy daily fractions, 5 fractions per week. Other Name: Radiation
|
Experimental: 4
Whole breast RT + tumour bed boost - Shorter fractionation schedule
|
Radiation: Whole breast RT plus tumour bed boost - Shorter schedule
Whole breast: A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight). Tumour bed: A total dose of 10 Gy in 4 fractions in 2.5-Gy daily fractions, 4 fractions per week. Other Name: Radiation
|
Detailed Description:
Specific objectives:
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.
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.
To compare the toxicity of:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
To compare the cosmetic outcome of:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
- To identify a molecular signature predictive of invasive recurrence of DCIS to facilitate therapy individualization.
- To assess inter-relationship of biomarkers and relationship between biomarker expression and specific histopathologic features of DCIS.
To evaluate the quality of life of women treated with:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
Contact: Boon Chua | +61 3 9656 1111 ext 1145 | Boon.Chua@petermac.org |
Show 110 Study Locations
Study Chair: | Boon Chua | Peter MacCallum Cancer Centre, Australia |
Additional Information:
No publications provided
Responsible Party: | Trans-Tasman Radiation Oncology Group (TROG) |
ClinicalTrials.gov Identifier: | NCT00470236 History of Changes |
Other Study ID Numbers: | TROG 07.01, NHMRC 454390, BIG 3-07, NCIC CTG MA.33, BOOG 2009-03, ICORG 10-06, EORTC 22085-10083, IBCSG 38-10, SCTBG 2009MayPR55 |
Study First Received: | May 3, 2007 |
Last Updated: | November 23, 2012 |
Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Ductal carcinoma in-situ Breast conserving therapy Whole breast radiation therapy |
Tumour bed boost Fractionation schedules Completely excised non-low risk DCIS |
Additional relevant MeSH terms:
Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Breast Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on March 06, 2013