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Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery. (SeqB vs SIB)

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ClinicalTrials.gov Identifier: NCT01973634
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE October 18, 2013
First Posted Date  ICMJE October 31, 2013
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy. [ Time Frame: weekly during radiotherapy, 2 weeks after the end of radiotherapy. ]
Clinical inspection of the treated breast.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
  • Degree of acute skin toxicity. [ Time Frame: Weekly during radiotherapy and 2 weeks after the end of radiotherapy. ]
    Clinical inspection.
  • Degree of chronic skin toxicity and cosmesis after radiotherapy. [ Time Frame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy. ]
    Inspection, clinical evaluation, digital photographs.
  • Quality of life after radiotherapy. [ Time Frame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy. ]
    QLQ C30 and QLQ BR23 quality of life questionnaires.
  • Biomarker analysis. [ Time Frame: Blood sample within 1 week before the start of radiotherapy ]
    Blood sample
  • Measurement of costs for the patient for the full treatment. [ Time Frame: Over the period of radiotherapy treatment, with a maximum of 5 weeks. ]
    Activity based costing models.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.
Official Title  ICMJE Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery
Brief Summary Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer halves the recurrence risk and reduces the breast cancer death by about one sixth. A sequential boost (SeqB) dose to the tumour bed further improves local control, but also increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI, the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time which is convenient for the patient and the radiotherapy department. In this study we wish to test the hypothesis of acceptable skin toxicity and reduced cost with SIB using hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose painting, a technique recently developed in our group. Patients are randomized between SeqB and SIB.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Breast Cancer Patients Needing Radiotherapy After Breast Conserving Surgery.
Intervention  ICMJE
  • Radiation: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)
    Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)
  • Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
    Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
  • Radiation: sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
    Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
  • Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
    Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
Study Arms  ICMJE
  • Active Comparator: Minimal surgical margin 1 mm, conventional arm: seq boost
    Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost).
    Intervention: Radiation: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)
  • Experimental: Minimal surgical margin of 1 mm, experimental arm with SIB
    Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
    Intervention: Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
  • Active Comparator: Minimal surgical margin <1 mm, conventional arm: seq boost
    Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
    Intervention: Radiation: sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
  • Experimental: Minimal surgical margin < 1 mm, experimental arm with SIB.
    Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
    Intervention: Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2013)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Female patients AND breast conserving surgery AND multidisciplinary decision of adjuvant WBI with a boost to the tumor bed AND age ≥ 18 years AND informed consent obtained, signed and dated before specific protocol procedures

Exclusion criteria

  • Mastectomy
  • Need for lymph node irradiation
  • No boost
  • Bilateral breast irradiation
  • Patient not able to reach or maintain the prone position
  • Pregnant or breastfeeding
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liv Veldeman, MD, PhD Liv.Veldeman@ugent.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973634
Other Study ID Numbers  ICMJE 2012/655
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP