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

Primary Purpose

Carcinoma, Ductal, Breast

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard WB fractionation
Shorter WB fractionation
Standard WB fractionation+Boost
Shorter WB fractionation + Boost
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Ductal, Breast focused on measuring Ductal carcinoma in-situ, Breast conserving therapy, Whole breast radiation therapy, Tumour bed boost, Fractionation schedules, Completely excised non-low risk DCIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Campbelltown Hospital
  • Nepean Cancer Care Centre
  • St George Hospital
  • Liverpool Hospital
  • Royal North Shore Hospital
  • Riverina Cancer Care Centre
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Premion - Wesley
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Genesis Cancer Care (previously Premion) - Nambour
  • Radiation Oncology - Mater Centre
  • Toowoomba Cancer Research Centre
  • North Queensland Oncology Service
  • Genesis Cancer Care (previously Premion) - Tugun
  • Royal Adelaide Hospital
  • Royal Hobart Hospital
  • Launceston General Hospital
  • Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital
  • Peter MacCallum Cancer Centre
  • Austin Hospital
  • William Buckland Radiotherapy Centre, Alfred Hospital
  • Sir Charles Gardiner Hospital
  • Royal Perth Hospital
  • Perth Radiation Oncology
  • Onze Lieve Vrouw Ziekenhuis
  • ZNA Middelheim
  • Cliniques Univeritaires St Luc
  • Universitair Zielenhusi
  • Hopital De Jolimont
  • AZ Groeninghe - Campus Maria's Voorzienigheid
  • Algemeen Ziekenhis Sint-Augustinus
  • Nova Scotia Cancer Centre
  • Jurvanski Cancer Centre
  • Notre Dame Hospital
  • BCCA Southern Interior - CAVK
  • London Regional Cancer Program
  • Saint John Regional Hospital
  • Leon Richard Oncology Centre
  • Hospital Maisonneuve-Rosemont
  • Lakeridge Health
  • CHUQ L'Hotel-Dieu de Quebec
  • McGill University Department of Oncology
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Universite de Sherbrooke - CUGH
  • Thunder Bay Regional Health Sciences Centre
  • Odette Cancer Centre
  • Princess Margaret Hospital
  • BCCA Vancouver Centre
  • Vancouver Island Cancer Centre
  • Cancer Care Manitoba
  • Chr De Grenoble - La Tronche
  • Centre Antine Lacassagne
  • Cork University Hospital
  • University Hospital Galway
  • SLRON (St Luke's Rad Onc Network)
  • Centro Di Riferimento Oncologico - Aviano
  • Fondazione Salvatore Maugeri
  • Academisch Medisch Centrum
  • Cancer Institute Antoni Van Leeuwenhoekziekenhuis
  • Arnhem 'S Radiotherapeutisch Instituut
  • Reinier de Graaf Groep
  • University Medical Centre Groningen
  • Leiden University Medical Centre
  • Maastricht Radiation Oncology Maastro Clinic
  • Medisch Centrum Haaglanden
  • ISALA Klinieken
  • Auckland Hospital
  • Christchurch Hospital
  • Waikato Hospital
  • National University Hospital
  • University Hospital Basel
  • IOSI
  • Inselspital Bern
  • Kantonsspital Graubunden
  • Kantonsspital Munsterlingen
  • Kantonsspital St. Gallen
  • Brust-Zentrum Zurich-Seefeld
  • Klinik Hirslanden
  • Gloucestershire Royal & Cheltenham General Hospitals
  • Churchill Hospital
  • Pilgram Hospital
  • Mount Vernon Cancer Centre
  • Ealing Hospital
  • Kings Mill Hospital Nottingham
  • Musgrove Park Hospital
  • Queens Hospital Burton
  • University of North Staffordshire
  • Aberdeen Royal Infirmary
  • Basildon University Hospital
  • Belfast City Hospital
  • Queen Elizabeth Hospital
  • Sandwell and West Birmingham Hospitals NHS Trust
  • Bristol Haematology & Oncology
  • Colchester Hospital
  • Coventry Arden Cancer Centre
  • Royal Derby Hospital
  • Dumfries & Galloway Royal Infirmary
  • Queen Margaret Hospital
  • Edinburgh Western General Hospital
  • The Beatson West of Scotland Cancer Centre
  • Royal Surrey County Hospital
  • Ipswich Hospital
  • Kidderminster Hospital
  • Leicester Royal Infirmary
  • Lincoln County Hospital
  • Imperial College Healthcare Charing Cross
  • James Cook University Hospital
  • Nottingham University Hospitals
  • Royal Alexandra Hospital
  • Alexandra Hospital
  • Weston Park Hospital
  • The Shrewsbury and Telford Hospital NHS Trust
  • Southend University Hopstial
  • Stafford Hospital
  • Royal Marsden
  • Warwick Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Arm 1 (Standard WB Fractionation)

Arm 2 (Shorter WB Fractionation)

Arm 3 (Standard WB fractionation+Boost)

Arm 4 (Shorter WB fractionation + Boost)

Arm Description

Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)

Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)

Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)

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

Outcomes

Primary Outcome Measures

Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence.

Secondary Outcome Measures

Overall survival
Time to disease recurrence
Cosmetic Outcome
Radiation toxicity
Quality of Life change

Full Information

First Posted
May 3, 2007
Last Updated
March 19, 2023
Sponsor
Trans Tasman Radiation Oncology Group
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
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1. Study Identification

Unique Protocol Identification Number
NCT00470236
Brief Title
Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
Acronym
DCIS
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Ductal, Breast
Keywords
Ductal carcinoma in-situ, Breast conserving therapy, Whole breast radiation therapy, Tumour bed boost, Fractionation schedules, Completely excised non-low risk DCIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1608 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (Standard WB Fractionation)
Arm Type
Active Comparator
Arm Description
Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)
Arm Title
Arm 2 (Shorter WB Fractionation)
Arm Type
Experimental
Arm Description
Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)
Arm Title
Arm 3 (Standard WB fractionation+Boost)
Arm Type
Active Comparator
Arm Description
Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)
Arm Title
Arm 4 (Shorter WB fractionation + Boost)
Arm Type
Experimental
Arm Description
Whole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)
Intervention Type
Radiation
Intervention Name(s)
Standard WB fractionation
Other Intervention Name(s)
Radiation
Intervention Description
A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
Intervention Type
Radiation
Intervention Name(s)
Shorter WB fractionation
Other Intervention Name(s)
Radiation
Intervention Description
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).
Intervention Type
Radiation
Intervention Name(s)
Standard WB fractionation+Boost
Other Intervention Name(s)
Radiation
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Shorter WB fractionation + Boost
Other Intervention Name(s)
Radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
Cosmetic Outcome
Time Frame
Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT.
Title
Radiation toxicity
Time Frame
Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.
Title
Quality of Life change
Time Frame
Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boon Chua
Organizational Affiliation
Prince of Wales Hospital Randwick
Official's Role
Study Chair
Facility Information:
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Nepean Cancer Care Centre
City
Kingswood
State/Province
New South Wales
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Riverina Cancer Care Centre
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Premion - Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Genesis Cancer Care (previously Premion) - Nambour
City
Nambour
State/Province
Queensland
Country
Australia
Facility Name
Radiation Oncology - Mater Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Toowoomba Cancer Research Centre
City
Toowoomba
State/Province
Queensland
Country
Australia
Facility Name
North Queensland Oncology Service
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4810
Country
Australia
Facility Name
Genesis Cancer Care (previously Premion) - Tugun
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
William Buckland Radiotherapy Centre, Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sir Charles Gardiner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Perth Radiation Oncology
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Onze Lieve Vrouw Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Facility Name
Cliniques Univeritaires St Luc
City
Brussel
Country
Belgium
Facility Name
Universitair Zielenhusi
City
Brussel
Country
Belgium
Facility Name
Hopital De Jolimont
City
Haine St Paul
Country
Belgium
Facility Name
AZ Groeninghe - Campus Maria's Voorzienigheid
City
Kortrijk
Country
Belgium
Facility Name
Algemeen Ziekenhis Sint-Augustinus
City
Wilrijk
Country
Belgium
Facility Name
Nova Scotia Cancer Centre
City
Halifax
Country
Canada
Facility Name
Jurvanski Cancer Centre
City
Hamilton
Country
Canada
Facility Name
Notre Dame Hospital
City
Hearst
Country
Canada
Facility Name
BCCA Southern Interior - CAVK
City
Kelowna
Country
Canada
Facility Name
London Regional Cancer Program
City
London
Country
Canada
Facility Name
Saint John Regional Hospital
City
Miramichi
Country
Canada
Facility Name
Leon Richard Oncology Centre
City
Moncton
Country
Canada
Facility Name
Hospital Maisonneuve-Rosemont
City
Montreal
Country
Canada
Facility Name
Lakeridge Health
City
Oshawa
Country
Canada
Facility Name
CHUQ L'Hotel-Dieu de Quebec
City
Quebec
Country
Canada
Facility Name
McGill University Department of Oncology
City
Sainte-Anne-de-Bellevue
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Saskatoon
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
Country
Canada
Facility Name
Universite de Sherbrooke - CUGH
City
Sherbrooke
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
Country
Canada
Facility Name
BCCA Vancouver Centre
City
Victoria
Country
Canada
Facility Name
Vancouver Island Cancer Centre
City
Victoria
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
Country
Canada
Facility Name
Chr De Grenoble - La Tronche
City
Grenoble
Country
France
Facility Name
Centre Antine Lacassagne
City
Nice
Country
France
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Facility Name
SLRON (St Luke's Rad Onc Network)
City
Rathgar
Country
Ireland
Facility Name
Centro Di Riferimento Oncologico - Aviano
City
Aviano
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam,
Country
Netherlands
Facility Name
Cancer Institute Antoni Van Leeuwenhoekziekenhuis
City
Amsterdam
Country
Netherlands
Facility Name
Arnhem 'S Radiotherapeutisch Instituut
City
Arnhem
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
Country
Netherlands
Facility Name
University Medical Centre Groningen
City
Groningen
Country
Netherlands
Facility Name
Leiden University Medical Centre
City
Leiden
Country
Netherlands
Facility Name
Maastricht Radiation Oncology Maastro Clinic
City
Maastricht
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
Westeinde
Country
Netherlands
Facility Name
ISALA Klinieken
City
Zwolle
Country
Netherlands
Facility Name
Auckland Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
IOSI
City
Bellinzona
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Kantonsspital Graubunden
City
Chur
Country
Switzerland
Facility Name
Kantonsspital Munsterlingen
City
Munsterlingen
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland
Facility Name
Brust-Zentrum Zurich-Seefeld
City
Zurich
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
Country
Switzerland
Facility Name
Gloucestershire Royal & Cheltenham General Hospitals
City
Cheltenham
State/Province
Gloucestershire
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
Headington
Country
United Kingdom
Facility Name
Pilgram Hospital
City
Boston
State/Province
Lincolnshire
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Ealing Hospital
City
Southall
State/Province
Middlesex
Country
United Kingdom
Facility Name
Kings Mill Hospital Nottingham
City
Sutton-In-Ashfield
State/Province
Nottinghamshire
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
Somerset
Country
United Kingdom
Facility Name
Queens Hospital Burton
City
Burton-On-Trent
State/Province
Staffordshire
Country
United Kingdom
Facility Name
University of North Staffordshire
City
Stoke-On-Trent
State/Province
Staffordshire
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
Country
United Kingdom
Facility Name
Basildon University Hospital
City
Basildon
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Sandwell and West Birmingham Hospitals NHS Trust
City
Birmingham
Country
United Kingdom
Facility Name
Bristol Haematology & Oncology
City
Bristol
Country
United Kingdom
Facility Name
Colchester Hospital
City
Colchester
Country
United Kingdom
Facility Name
Coventry Arden Cancer Centre
City
Coventry
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom
Facility Name
Dumfries & Galloway Royal Infirmary
City
Dumfries
Country
United Kingdom
Facility Name
Queen Margaret Hospital
City
Dunfermline
Country
United Kingdom
Facility Name
Edinburgh Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
Country
United Kingdom
Facility Name
Kidderminster Hospital
City
Kidderminster
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
Country
United Kingdom
Facility Name
Imperial College Healthcare Charing Cross
City
London
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesborough
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
Country
United Kingdom
Facility Name
Alexandra Hospital
City
Redditch
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
Country
United Kingdom
Facility Name
The Shrewsbury and Telford Hospital NHS Trust
City
Shrewsbury
Country
United Kingdom
Facility Name
Southend University Hopstial
City
Southend
Country
United Kingdom
Facility Name
Stafford Hospital
City
Stafford
Country
United Kingdom
Facility Name
Royal Marsden
City
Sutton
Country
United Kingdom
Facility Name
Warwick Hospital
City
Warwick
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35934006
Citation
Chua BH, Link EK, Kunkler IH, Whelan TJ, Westenberg AH, Gruber G, Bryant G, Ahern V, Purohit K, Graham PH, Akra M, McArdle O, O'Brien P, Harvey JA, Kirkove C, Maduro JH, Campbell ID, Delaney GP, Martin JD, Vu TTT, Muanza TM, Neal A, Olivotto IA; BIG 3-07/TROG 07.01 trial investigators. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study. Lancet. 2022 Aug 6;400(10350):431-440. doi: 10.1016/S0140-6736(22)01246-6.
Results Reference
derived
PubMed Identifier
32203696
Citation
King MT, Link EK, Whelan TJ, Olivotto IA, Kunkler I, Westenberg AH, Gruber G, Schofield P, Chua BH; BIG 3-07/TROG 07.01 trial investigators. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):685-698. doi: 10.1016/S1470-2045(20)30085-1. Epub 2020 Mar 20.
Results Reference
derived
Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website

Learn more about this trial

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

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