Breast CancerNCT00909818
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
A study testing standard fractionated radiotherapy and hypofractionated radiotherapy in people with Breast Cancer and Carcinoma in Situ of the Breast, run by Danish Breast Cancer Cooperative Group at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer. Read more about this study
- Who is it for?
- Ages 41 years and older, women only
- Conditions the study is for
- Breast Cancer, Carcinoma in Situ of the Breast
- What is being tested?
- standard fractionated radiotherapy and hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 976 participants
- Where
- 1 siteDenmark
- Study dates
- 14 May 2009to May 2024
- 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 41 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- operated with breast conserving strategy for:
- invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- carcinoma in situ of the breast
Who cannot join
- previous radiation of the breast/thorax
- breast implants
- pregnant/lactating
- comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Danish Breast Cancer Cooperative Group
Copenhagen, DK-2100 Ø
About this study
Official title: Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.
Read the detailed description
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.
The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
- Conditions
- Breast Cancer, Carcinoma in Situ of the Breast
- Being tested
- standard fractionated radiotherapy, hypofractionated radiotherapy
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard fractionated radiotherapyRadiation
standard fractionated radiotherapy 50 Gy/25 fractions
hypofractionated radiotherapyRadiation
hypofractionated radiotherapy 40 Gy/15 fractions
| Study group | Role | What they receive |
|---|---|---|
| standard fractionated radiotherapy | Active comparator | 50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week Receives: Radiation: standard fractionated radiotherapy |
| hypofractionated radiotherapy | Experimental | hypofractionated radiotherapy 40 Gy/15 fractions Receives: Radiation: hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 or 3 fibrosis 3 years after radiotherapy
Measured: 3 years
Secondary outcomes (1)
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study start14 May 2009
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 976 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Birgitte Offersen, Danish Breast Cancer Cooperative Group
- Investigators
- Lars Stenbygaard, MD, Study chair, Aalborg University HospitalBirgitte Offersen, MD, Ph.D, Study chair, Aarhus University HospitalErik Jakobsen, MD, Study chair, Vejle HospitalMette H Nielsen, MD, phd, Study chair, Odense University HospitalBirgitte Offersen, MD, phd, Principal investigator, Aarhus University HospitalMechthild Krause, M.D., Prof, Study chair, University Clinic Carl Gustav Carus DresdenAndreas Schreiber, M.D., Ph.D., Study chair, Praxis für Strahlentherapie am Klinikum Dresden-FriedrichstadtIngvil Mjaaland, M.D., Study chair, Helse Stavanger HF, Sorlandet Sykehus HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909818
- Sponsor's protocol ID
- DBCG hypo protocol
- Other IDs
- CIRRO IP030209, The Danish Cancer Society
- Status last verified
- Aug 2021
- First submitted
- 28 May 2009
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.
PubMed 32910709
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
- ClinicalTrials.gov ID
- NCT00909818
- Acronym / sponsor ID
- DBCG hypo protocol
- Conditions
- Breast Cancer, Carcinoma in Situ of the Breast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 976 participants (estimated)
- Lead sponsor
- Danish Breast Cancer Cooperative GroupUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 14 May 2009 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 29 May 2009 (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.
The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.
Detailed description
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.
The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard fractionated radiotherapy | Active comparator | Radiation: standard fractionated radiotherapy50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week |
| hypofractionated radiotherapy | Experimental | Radiation: hypofractionated radiotherapyhypofractionated radiotherapy 40 Gy/15 fractions |
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- operated with breast conserving strategy for:
Key exclusion criteria (4 listed)
- previous radiation of the breast/thorax
- breast implants
- pregnant/lactating
- comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
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 |
|---|---|---|
| standard fractionated radiotherapystandard fractionated radiotherapy 50 Gy/25 fractions | Radiation | standard fractionated radiotherapy |
| hypofractionated radiotherapyhypofractionated radiotherapy 40 Gy/15 fractions | Radiation | hypofractionated radiotherapy |
Primary outcome
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time frame: 3 years
1 secondary outcome
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 32910709Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.
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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.
Lars Stenbygaard, MD study chair
Aalborg University Hospital
Birgitte Offersen, MD, Ph.D study chair
Aarhus University Hospital
Erik Jakobsen, MD study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard fractionated radiotherapy and hypofractionated radiotherapy in people with Breast Cancer and Carcinoma in Situ of the Breast, run by Danish Breast Cancer Cooperative Group at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. 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 Denmark. 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?
Grade 2 or 3 fibrosis 3 years after radiotherapy (time frame: 3 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 NCT00909818, 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 24 Aug 2021.