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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

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.

Condition or disease Intervention/treatment Phase
Early Breast Cancer Patients Needing Radiotherapy After Breast Conserving Surgery. Radiation: 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) Radiation: 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) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery
Study Start Date : December 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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)

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)
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)

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)
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)

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)
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Degree of acute skin toxicity. [ Time Frame: Weekly during radiotherapy and 2 weeks after the end of radiotherapy. ]
    Clinical inspection.

  2. 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.

  3. 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.

  4. Biomarker analysis. [ Time Frame: Blood sample within 1 week before the start of radiotherapy ]
    Blood sample

  5. 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.



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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:

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

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): NCT01973634


Contacts
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Contact: Liv Veldeman, MD, PhD Liv.Veldeman@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Liv Veldeman, MD, PhD       Liv.Veldeman@ugent.be   
Sub-Investigator: Liv Veldeman, MD, PhD         
Principal Investigator: Wilfried De Neve, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent

Additional Information:
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01973634     History of Changes
Other Study ID Numbers: 2012/655
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Radiotherapy