TumorsPhase 3KOSIMANCT01403779
Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer
A Phase 3 study testing intensity modulated radiotherapy (IMRT) for breast cancer in people with Tumors and Breast Cancer, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Tumors, Breast Cancer
- What is being tested?
- intensity modulated radiotherapy (IMRT) for breast cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to 2 Feb 2017
- Phase
- Phase 3
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3, pN0-1a, M0
- Age ≥ 60 years
- signed informed consent from the patient
Who cannot join
- Stage pN1b-PN3, pT4 and / or M1
- incomplete surgical resection
- after mastectomy of the ipsilateral or contralateral breast
- breast reconstruction with implant or expander insert
- bilateral breast cancer
- Lack of compliance or consent
- Indications for irradiation of the axillary, supraclavicular or parasternal lymph nodes
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiotherapy University Hospital Mannheim
Mannheim, 68167
About this study
Official title: Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial
Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized.
This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques.
Read more
The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life.
Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).
In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied.
Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization.
For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period.
A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years.
Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).
- Conditions
- Tumors, Breast Cancer
- Being tested
- intensity modulated radiotherapy (IMRT) for breast cancer
- Keywords
- Intensity-Modulated Radiation Therapy (IMRT), Breast cancer, Hypofractionation
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity modulated radiotherapy (IMRT) for breast cancerRadiation
Also called Arm 1, Arm 2
right sided breast cancer patients are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer patients a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).
| Study group | Role | What they receive |
|---|---|---|
| 1-Hypofractionated IMRT | Active comparator | hypofractionated IMRT for right sided breast cancer Receives: Radiation: intensity modulated radiotherapy (IMRT) for breast cancer |
| 2-Normofractioated IMRT | Active comparator | normofractionated IMRT for left sided breast cancer Receives: Radiation: intensity modulated radiotherapy (IMRT) for breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute and chronic cosmetic outcome
Measured: 2 years
Secondary outcomes (1)
acute and chronic cosmetic outcome, Quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJul 2010
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
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 TumorsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Wenz, Universitätsmedizin Mannheim
- Investigators
- Frederik Wenz, MD, Study chair, UMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403779
- Sponsor's protocol ID
- MA-KOSIMA-01
- Other IDs
- ARO 2010-3
- Acronym
- KOSIMA
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2010
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Sarria GR, Welzel G, Polednik M, Wenz F, Abo-Madyan Y. Prospective Comparison of Hypofractionated Versus Normofractionated Intensity-Modulated Radiotherapy in Breast Cancer: Late Toxicity Results of the Non-Inferiority KOSIMA Trial (ARO2010-3). Front Oncol. 2022 May 5;12:824891. doi: 10.3389/fonc.2022.824891. eCollection 2022.
PubMed 35600361
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial
- ClinicalTrials.gov ID
- NCT01403779
- Acronym / sponsor ID
- KOSIMA / MA-KOSIMA-01
- Conditions
- Tumors, Breast Cancer
- Keywords
- Intensity-Modulated Radiation Therapy (IMRT), Breast cancer, Hypofractionation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 27 Jul 2011 (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.
Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized.
This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques.
The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life.
Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).
In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied.
Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization.
For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period.
A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years.
Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Hypofractionated IMRT | Active comparator | Radiation: intensity modulated radiotherapy (IMRT) for breast cancerhypofractionated IMRT for right sided breast cancer |
| 2-Normofractioated IMRT | Active comparator | Radiation: intensity modulated radiotherapy (IMRT) for breast cancernormofractionated IMRT for left sided breast cancer |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3, pN0-1a, M0
- Age ≥ 60 years
- signed informed consent from the patient
Key exclusion criteria (7 listed)
- Stage pN1b-PN3, pT4 and / or M1
- incomplete surgical resection
- after mastectomy of the ipsilateral or contralateral breast
- breast reconstruction with implant or expander insert
- bilateral breast cancer
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 |
|---|---|---|
| intensity modulated radiotherapy (IMRT) for breast cancerAlso: Arm 1, Arm 2right sided breast cancer patients are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer patients a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy). | Radiation | 1-Hypofractionated IMRT, 2-Normofractioated IMRT |
Primary outcome
acute and chronic cosmetic outcome
Time frame: 2 years
1 secondary outcome
acute and chronic cosmetic outcome, Quality of life
Time frame: 2 years
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 7 Nov 2022.
- Results publication: PubMed 35600361Sarria GR, Welzel G, Polednik M, Wenz F, Abo-Madyan Y. Prospective Comparison of Hypofractionated Versus Normofractionated Intensity-Modulated Radiotherapy in Breast Cancer: Late Toxicity Results of the Non-Inferiority KOSIMA Trial (ARO2010-3). Front Oncol. 2022 May 5;12:824891. doi: 10.3389/fonc.2022.824891. eCollection 2022.
- German AbstractLink provided by the sponsor.
- English AbstractLink provided by the sponsor.
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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.
Frederik Wenz, MD study chair
UMM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intensity modulated radiotherapy (IMRT) for breast cancer in people with Tumors and Breast Cancer, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 7 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 7 Nov 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
acute and chronic cosmetic outcome (time frame: 2 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 NCT01403779, 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 Nov 2022.