Radiotherapy After Breast Conserving SurgeryPhase 2SeqB vs SIBNCT01973634

Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.

A Phase 2 study testing sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost), SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy) and sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost) in people with Radiotherapy After Breast Conserving Surgery, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Radiotherapy After Breast Conserving Surgery
What is being tested?: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost), SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy) and sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteBelgium
Study dates: Dec 2012to Mar 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University Hospital
Ghent, 9000

Other trials in Belgium

About this study

Official title: 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.

Conditions: Radiotherapy After Breast Conserving Surgery
Being tested: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost), SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy), sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost), SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
Keywords: Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)Radiation
Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)
SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)Radiation
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)
sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)Radiation
Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)Radiation
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 groups in NCT01973634
Study group	Role	What they receive
Minimal surgical margin 1 mm, conventional arm: seq boost	Active comparator	Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost). Receives: Radiation: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)
Minimal surgical margin of 1 mm, experimental arm with SIB	Experimental	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) Receives: Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
Minimal surgical margin <1 mm, conventional arm: seq boost	Active comparator	Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost) Receives: Radiation: sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
Minimal surgical margin < 1 mm, experimental arm with SIB.	Experimental	Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy) Receives: Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.
Clinical inspection of the treated breast.
Measured: weekly during radiotherapy, 2 weeks after the end of radiotherapy.

Secondary outcomes (5)

Degree of acute skin toxicity.
Clinical inspection.
Measured: Weekly during radiotherapy and 2 weeks after the end of radiotherapy.
Degree of chronic skin toxicity and cosmesis after radiotherapy.
Inspection, clinical evaluation, digital photographs.
Measured: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.
Quality of life after radiotherapy.
QLQ C30 and QLQ BR23 quality of life questionnaires.
Measured: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.
Biomarker analysis.
Blood sample
Measured: Blood sample within 1 week before the start of radiotherapy
Measurement of costs for the patient for the full treatment.
Activity based costing models.
Measured: Over the period of radiotherapy treatment, with a maximum of 5 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Mar 2021

First posted31 Oct 2013 (estimated)
Study startDec 2012
Primary completionDec 2015
Study completionMar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Radiotherapy After Breast Conserving SurgeryStudies of the same condition, open and under way.
More trials run by University Hospital, GhentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01973634
Sponsor's protocol ID: 2012/655
Acronym: SeqB vs SIB
Status last verified: Nov 2022
First submitted: 18 Oct 2013
Last updated: 2 Dec 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Radiotherapy After Breast Conserving Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery
ClinicalTrials.gov ID: NCT01973634
Acronym / sponsor ID: SeqB vs SIB / 2012/655
Conditions: Radiotherapy After Breast Conserving Surgery
Keywords: Radiotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Study start: Dec 2012 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Mar 2021 (actual)
First posted: 31 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Minimal surgical margin 1 mm, conventional arm: seq boost	Active comparator	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).
Minimal surgical margin of 1 mm, experimental arm with SIB	Experimental	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)
Minimal surgical margin <1 mm, conventional arm: seq boost	Active comparator	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)
Minimal surgical margin < 1 mm, experimental arm with SIB.	Experimental	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)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

Mastectomy
Need for lymph node irradiation
No boost
Bilateral breast irradiation
Patient not able to reach or maintain the prone position

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Minimal surgical margin 1 mm, conventional arm: seq boost
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	Minimal surgical margin of 1 mm, experimental arm with SIB
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	Minimal surgical margin <1 mm, conventional arm: seq boost
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)	Radiation	Minimal surgical margin < 1 mm, experimental arm with SIB.

Primary outcome

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.

5 secondary outcomes

Degree of acute skin toxicity.
Time frame: 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.
Quality of life after radiotherapy.
Time frame: 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
Measurement of costs for the patient for the full treatment.
Time frame: Over the period of radiotherapy treatment, with a maximum of 5 weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
Related InfoLink provided by the sponsor.

Related trials for Radiotherapy After Breast Conserving Surgery

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Intraoperative Radiation Therapy (IORT) in DCIS
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IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
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Active, not recruiting
Partial Breast Re-irradiation for Breast Cancer
Breast Cancers
Recruiting
1-Week Versus 3-Week PBI
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Recruiting
Efficacy of Kinesio Taping Versus Compression Therapy on Breast Lymphedema Induced by Radiotherapy After Breast-Conserving Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wilfried De Neve, MD, PhD principal investigator

University Hospital, Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01973634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.