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Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast (DCIS)

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ClinicalTrials.gov Identifier: NCT00470236
Recruitment Status : Active, not recruiting
First Posted : May 7, 2007
Last Update Posted : March 22, 2023
Sponsor:
Collaborators:
Breast International Group
NCIC Clinical Trials Group
Cancer Trials Ireland
Borstkanker Onderzoek Groep
ETOP IBCSG Partners Foundation
Scottish Cancer Trials Breast Group
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Trans Tasman Radiation Oncology Group

Study Description
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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 risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
  3. 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:

  1. To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
  2. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

Condition or disease Intervention/treatment Phase
Carcinoma, Ductal, Breast Radiation: Standard WB fractionation Radiation: Shorter WB fractionation Radiation: Standard WB fractionation+Boost Radiation: Shorter WB fractionation + Boost Not Applicable

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 boost;
    • RT using the standard fractionation schedule versus the shorter schedule.

  2. 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.

  3. 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.

  4. 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.
  5. To identify a molecular signature predictive of invasive recurrence of DCIS to facilitate therapy individualization.
  6. To assess inter-relationship of biomarkers and relationship between biomarker expression and specific histopathologic features of DCIS.

  7. 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2007
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1 (Standard WB Fractionation)
Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)
 Radiation: Standard WB fractionation
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: Arm 2 (Shorter WB Fractionation)
Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)
 Radiation: Shorter WB fractionation
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: Arm 3 (Standard WB fractionation+Boost)
Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)
 Radiation: Standard WB fractionation+Boost

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: Arm 4 (Shorter WB fractionation + Boost)
Whole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)
 Radiation: Shorter WB fractionation + Boost

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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Cosmetic Outcome [ Time Frame: Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT. ]
  4. Radiation toxicity [ Time Frame: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10. ]
  5. Quality of Life change [ Time Frame: Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470236


Locations
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Sponsors and Collaborators
Trans Tasman Radiation Oncology Group
Breast International Group
NCIC Clinical Trials Group
Cancer Trials Ireland
Borstkanker Onderzoek Groep
ETOP IBCSG Partners Foundation
Scottish Cancer Trials Breast Group
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Boon Chua Prince of Wales Hospital Randwick
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trans Tasman Radiation Oncology Group
ClinicalTrials.gov Identifier: NCT00470236    
Other Study ID Numbers: TROG 07.01
NHMRC 454390 ( Other Grant/Funding Number: NHMRC )
BIG 3-07 ( Other Identifier: Collaborative Group )
NCIC CTG MA.33 ( Other Identifier: Collaborative Group )
BOOG 2009-03 ( Other Identifier: Collaborative Group )
ICORG 10-06 ( Other Identifier: Collaborative Group )
EORTC 22085-10083 ( Other Identifier: Collaborative Group )
IBCSG 38-10 ( Other Identifier: Collaborative Group )
SCTBG 2009MayPR55 ( Other Identifier: Collaborative Group )
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Keywords provided by Trans Tasman Radiation Oncology Group:
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:
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Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases