- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973634
Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery. (SeqB vs SIB)
November 29, 2022 updated by: University Hospital, Ghent
Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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).
|
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)
|
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)
|
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)
|
Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33
Gy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
weekly during radiotherapy, 2 weeks after the end of radiotherapy.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of acute skin toxicity.
Time Frame: Weekly during radiotherapy and 2 weeks after the end of radiotherapy.
|
Clinical inspection.
|
Weekly during radiotherapy and 2 weeks after the end of radiotherapy.
|
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.
|
2 weeks, 1 year, 2 years and 5 years after radiotherapy.
|
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.
|
2 weeks, 1 year, 2 years and 5 years after radiotherapy.
|
Biomarker analysis.
Time Frame: Blood sample within 1 week before the start of radiotherapy
|
Blood sample
|
Blood sample within 1 week before the start of radiotherapy
|
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.
|
Over the period of radiotherapy treatment, with a maximum of 5 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2012
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
March 1, 2021
Study Registration Dates
First Submitted
October 18, 2013
First Submitted That Met QC Criteria
October 25, 2013
First Posted (ESTIMATE)
October 31, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2022
Last Update Submitted That Met QC Criteria
November 29, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2012/655
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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