Breast CancerNCT04535895
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
A study testing Simultaneous integrated boost in people with Breast Cancer and Radiotherapy Side Effect, run by Medical University of Graz at 1 site in Austria.
Trial summary
Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy Side Effect
- What is being tested?
- Simultaneous integrated boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 16 Apr 2020to 31 Aug 2025
- Phase
- Interventional
- 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
- Invasive breast cancer or ductal carcinoma in situ
- Breast conserving surgery
- Complete tumor resection
- Treatment with adjuvant radiotherapy of the breast
- Indication for boost Irradiation
- Given informed consent
Who cannot join
- Incomplete tumor resection
- Mastectomy
- Distant metastases at diagnosis
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.
Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.
Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.
The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Being tested
- Simultaneous integrated boost
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous integrated boostRadiation
Adjuvant breast cancer irradiation including simultaneous integrated boost
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous integrated boost arm | Experimental | Not described Receives: Radiation: Simultaneous integrated boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Radiation induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: Measurement at the last 1 day of radiotherapy
Acute Radiation induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: Measurement 3 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start16 Apr 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2025 (estimated)
Why it stopped: Treatment standard has changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Langsenlehner, MD, Principal investigator, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535895
- Sponsor's protocol ID
- 1094/2020
- Status last verified
- Oct 2022
- First submitted
- 25 Aug 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hurkmans CW, Dijckmans I, Reijnen M, van der Leer J, van Vliet-Vroegindeweij C, van der Sangen M. Adaptive radiation therapy for breast IMRT-simultaneously integrated boost: three-year clinical experience. Radiother Oncol. 2012 May;103(2):183-7. doi: 10.1016/j.radonc.2011.12.014. Epub 2012 Jan 24.
PubMed 22280808
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT04535895
- Acronym / sponsor ID
- 1094/2020
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Treatment standard has changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 2 Sep 2020 (actual)
- 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.
Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.
Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.
The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous integrated boost arm | Experimental | Radiation: Simultaneous integrated boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Invasive breast cancer or ductal carcinoma in situ
- Breast conserving surgery
- Complete tumor resection
- Treatment with adjuvant radiotherapy of the breast
- Indication for boost Irradiation
Key exclusion criteria (4 listed)
- Incomplete tumor resection
- Mastectomy
- Distant metastases at diagnosis
- Unable to give informed consent
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 |
|---|---|---|
| Simultaneous integrated boostAdjuvant breast cancer irradiation including simultaneous integrated boost | Radiation | Simultaneous integrated boost arm |
Primary outcome
Acute Radiation induced toxicity (grade 2 or higher)
Time frame: Measurement at the last 1 day of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Acute Radiation induced toxicity (grade 2 or higher)
Time frame: Measurement 3 months after completion of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 22280808Hurkmans CW, Dijckmans I, Reijnen M, van der Leer J, van Vliet-Vroegindeweij C, van der Sangen M. Adaptive radiation therapy for breast IMRT-simultaneously integrated boost: three-year clinical experience. Radiother Oncol. 2012 May;103(2):183-7. doi: 10.1016/j.radonc.2011.12.014. Epub 2012 Jan 24.
- Individual participant dataSharing planned: No
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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.
Tanja Langsenlehner, MD principal investigator
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous integrated boost in people with Breast Cancer and Radiotherapy Side Effect, run by Medical University of Graz at 1 site in Austria.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Oct 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 Austria. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Acute Radiation induced toxicity (grade 2 or higher) (time frame: Measurement at the last 1 day of radiotherapy). The study lists 2 primary outcomes in all. 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 NCT04535895, which also lists 1 linked publication.
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 12 Oct 2022.