Breast CancerFUSIBNCT02505906
Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique
An observational study of Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Simultaneous Integrated Boost Technique
- Type of treatment
- Surgery or procedure
- How many people
- 5,043 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to 1 Sep 2017
- How long will I take part?
- 5 Years
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer treated with curative intent.
Who may be able to join
- WHO performance status 0-2.
- Invasive breast cancer or ductal carcinoma in situ (DCIS).
- Stage I-III breast cancer or DCIS.
- Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.
Who cannot join
- Previous thoracic radiotherapy.
- Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- Bilateral (synchrone) invasive breast cancer.
- Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
- Distant metastases at diagnosis (M1).
- Unsufficient knowledge of Dutch language.
Trial locations and contacts
1 site in 1 country.
About this study
In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.
- Conditions
- Breast Cancer
- Being tested
- Simultaneous Integrated Boost Technique
- Keywords
- Late toxicity, Simultaneous integrated boost (SIB), Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Integrated Boost TechniqueRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Late radiation-induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: At 1 year after completion of radiation therapy
Late radiation-induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: At 2 years after completion of radiation therapy
Late radiation-induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: At 3 years after completion of radiation therapy
Late radiation-induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: At 4 years after completion of radiation therapy
Late radiation-induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: At 5 years after completion of radiation therapy
Secondary outcomes (6)
Overall survival
Measured: At 1,2,3,4 and 5 years after completion of radiation therapy
Patient-rated symptoms
Questionnaire: BCSCQ
Measured: At 1,2,3,4 and 5 years after completion of radiation therapy
Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery
Questionnaires: European Organization for Research and Treatment of Cancer Quality of Life - Core Questionnaire (EORTC QLQ-C30), Quality of Life Questionnaire - Breast Cancer Module (QLQ-BR23) and Adult Comorbidity Evaluation (ACE-27)
Measured: At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (local)
Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound
Measured: At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (regional)
Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound
Measured: At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (distant metastasis)
Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound
Measured: At 1,2,3,4 and 5 years after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJan 2008
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,043 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505906
- Sponsor's protocol ID
- SFP2008-06
- Acronym
- FUSIB
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique
- ClinicalTrials.gov ID
- NCT02505906
- Acronym / sponsor ID
- FUSIB / SFP2008-06
- Conditions
- Breast Cancer
- Keywords
- Late toxicity, Simultaneous integrated boost (SIB), Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,043 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 22 Jul 2015 (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 summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer treated with curative intent.
Key inclusion criteria (4 listed)
- WHO performance status 0-2.
- Invasive breast cancer or ductal carcinoma in situ (DCIS).
- Stage I-III breast cancer or DCIS.
- Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.
Key exclusion criteria (6 listed)
- Previous thoracic radiotherapy.
- Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- Bilateral (synchrone) invasive breast cancer.
- Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
- Distant metastases at diagnosis (M1).
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 Boost Technique | Radiation | – |
Primary outcome
Late radiation-induced toxicity (grade 2 or higher)
Time frame: At 1 year after completion of radiation therapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Late radiation-induced toxicity (grade 2 or higher)
Time frame: At 2 years after completion of radiation therapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Late radiation-induced toxicity (grade 2 or higher)
Time frame: At 3 years after completion of radiation therapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Late radiation-induced toxicity (grade 2 or higher)
Time frame: At 4 years after completion of radiation therapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Late radiation-induced toxicity (grade 2 or higher)
Time frame: At 5 years after completion of radiation therapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
6 secondary outcomes
Overall survival
Time frame: At 1,2,3,4 and 5 years after completion of radiation therapy
Patient-rated symptoms
Time frame: At 1,2,3,4 and 5 years after completion of radiation therapy
Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery
Time frame: At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (local)
Time frame: At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (regional)
Time frame: At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (distant metastasis)
Time frame: At 1,2,3,4 and 5 years after completion of radiation therapy
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 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 6 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 28 Feb 2024. 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 Netherlands. 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 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?
Late radiation-induced toxicity (grade 2 or higher) (time frame: At 1 year after completion of radiation therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.