Adverse Effect of Radiation TherapyNCT02114086
IORT-Boost-Study, Prospective Observational Study for Intraoperative Radiotherapy of the Breast as a Boost
An observational study of Adverse Effect of Radiation Therapy, run by Kantonsspital Münsterlingen at 1 site in Switzerland.
Trial summary
In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Adverse Effect of Radiation Therapy
- How many people
- 163 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to 31 Aug 2025
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: women with breast cancer breast-conserving therapy
Who may be able to join
- women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor < or = 3.5 cm
- written informed consent
- ability to cooperate
- full legal capability
Who cannot join
- missing written informed consent
- lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost
In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.
- Conditions
- Adverse Effect of Radiation Therapy
- Keywords
- Observational Study, intraoperative Radiation of Breast Cancer, early and late effects of radiation, cosmesis and quality of life
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | observation of intraoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Participants with local recurrence histologically proven
Recurrence of breast cancer proven by histology
Measured: up to 10 years
Secondary outcomes (4)
observation of acute and late effects of Radiotherapy
acute effects of Radiotherapy are assessed by Common Toxicity Criteria for Adverse Effects (CTCAE Version 4.0) and late effects of Radiotherapy are assessed by Late Effects Normal Tissue Subjective Objective Management Analysis (LENT-SOMA)
Measured: up to 10 years
Overall survival
The number of Patients who died is assessed.
Measured: up to 10 years
Quality of life
Quality of life is assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) cancer modul (C30) EORTC-QLQ-C30 version 3.0 and breast cancer modul (BR23) EORTC-QLQ-BR23
Measured: up to 10 years
Cosmesis
Cosmesis is assessed by Photographs and evaluated automatically.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2019
- Study completion31 Aug 2025 (estimated)
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 Adverse Effect of Radiation TherapyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Münsterlingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christiane Reuter, Dr. med., Study director, Kantonsspital Münsterlingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114086
- Sponsor's protocol ID
- ROKSM 01/12
- Other IDs
- KMünsterlingen
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2013
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.
PubMed 17577015
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost
- ClinicalTrials.gov ID
- NCT02114086
- Acronym / sponsor ID
- ROKSM 01/12
- Conditions
- Adverse Effect of Radiation Therapy
- Keywords
- Observational Study, intraoperative Radiation of Breast Cancer, early and late effects of radiation, cosmesis and quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Kantonsspital MünsterlingenUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 15 Apr 2014 (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.
In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer | – | –observation of intraoperative radiotherapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women with breast cancer breast-conserving therapy
Key inclusion criteria (4 listed)
- women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor < or = 3.5 cm
- written informed consent
- ability to cooperate
- full legal capability
Key exclusion criteria (2 listed)
- missing written informed consent
- lack of compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of Participants with local recurrence histologically proven
Time frame: up to 10 years
Recurrence of breast cancer proven by histology
4 secondary outcomes
observation of acute and late effects of Radiotherapy
Time frame: up to 10 years
Overall survival
Time frame: up to 10 years
Quality of life
Time frame: up to 10 years
Cosmesis
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 17577015Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.
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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.
Christiane Reuter, Dr. med. study director
Kantonsspital Münsterlingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effect of Radiation Therapy, run by Kantonsspital Münsterlingen at 1 site in Switzerland.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Sep 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 Switzerland. 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?
Results are not available in the source record.
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?
number of Participants with local recurrence histologically proven (time frame: up to 10 years). 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 NCT02114086, 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 7 Sep 2022.