Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With BoostNCT01948726
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
A study testing Hypofractionation with simultaneous integrated boost in people with Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost, run by University Hospital Schleswig-Holstein at 19 sites in Germany.
Trial summary
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost
- What is being tested?
- Hypofractionation with simultaneous integrated boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 19 sitesGermany
- Study dates
- Dec 2013to Mar 2015
- 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
- Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- Indication to adjuvant radiotherapy including boost radiotherapy
- Clearly identified primary tumor region preferably by radiopaque clips
- Primary wound healing after breast conserving therapy without signs of infection
- Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
- Written informed consent
Who cannot join
- Patients operated by mastectomy
- No indication for boost radiation
- Resection margins positive for disease or insufficient identification of the boost volume
- Indication for radiotherapy of the regional lymph nodes
- History of prior breast or thoracic radiotherapy
- Extended postoperative seroma at the beginning of radiotherapy
- Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
- Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Charité University Medical Center Berlin
Berlin, 10117
Krankenhaus Buchholz
Buchholz, 21244
Klinikum des Landkreises Deggendorf Mammazentrum
Deggendorf, 94469
Praxis für Strahlentherapie am Krankenhaus Dresden-Friedrichstadt
Dresden, 01067
Malteser St. Franziskus-Hospital
Flensburg, 24939
Onkologischer Schwerpunkt (OSP) Goeppingen
Göppingen, 73006
Strahlenzentrum Hamburg Nord
Hamburg, 22419
Radiologie and Radioonkologie
Hamburg, 22767
University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Kiel
Kiel, 24105
University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Luebeck
Lübeck, 23538
MGZ Luebeck im Hochschulstadtteil
Lübeck, 23562
Staedtisches Klinikum Lueneburg
Lüneburg, 21339
University Medical Center Mainz, Department of Radiotherapy
Mainz, 55131
University Medical Center Rechts der Isar Department of Radiotherapy Muenchen
München, 81675
Radiology Pinneberg
Pinneberg, 25421
Helios Kliniken Schwerin
Schwerin, 19049
Johanniter-Krankenhaus Genthin-Stendal
Stendal, 39576
MVZ Klinikum Straubing GmbH
Straubing, 94315
Heinrich-Braun-Klinikum Zwickau
Zwickau, 08060
About this study
Official title: Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies.
Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.
Read the detailed description
Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).
- Conditions
- Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost
- Being tested
- Hypofractionation with simultaneous integrated boost
- Keywords
- Breast cancer, Hypofractionation, Simultaneous integrated boost, Toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionation with simultaneous integrated boostRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation with SIB | Experimental | Not described Receives: Radiation: Hypofractionation with simultaneous integrated boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Skin Toxicity
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Measured: 6 months
Secondary outcomes (4)
Number of Patients treated on Protocol
Dose constraints Dmedian lung < 10 Gy; Dmedian heart < 5 Gy, Dmax ≤ 40 Gy; Dmedian anterior branch of the left coronary artery (LAD, RIVA) < 15 Gy, Dmax ≤ 40 Gy; Dmedian contralateral breast < 3 Gy
Measured: 22-29 days (16 fractions)
Acute General Toxicity
All dimensions of NCI-CTCAE
Measured: 0 to 6 months
Quality of life Score
EORTC QLQ-C30, -BR23
Measured: 0 to 6 months
Performance
ECOG
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With BoostStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Principal investigator, Juergen Dunst, Prof., University Hospital Schleswig-Holstein
- Investigators
- Juergen Dunst, Prof., Study chair, University Medical Center Schleswig-Holstein (UKSH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948726
- Sponsor's protocol ID
- ARO 2013-04
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2013
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01948726
- Acronym / sponsor ID
- ARO 2013-04
- Conditions
- Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost
- Keywords
- Breast cancer, Hypofractionation, Simultaneous integrated boost, Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Sep 2013 (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.
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies.
Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.
Detailed description
Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation with SIB | Experimental | Radiation: Hypofractionation with 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)
- Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- Indication to adjuvant radiotherapy including boost radiotherapy
- Clearly identified primary tumor region preferably by radiopaque clips
- Primary wound healing after breast conserving therapy without signs of infection
- Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
Key exclusion criteria (8 listed)
- Patients operated by mastectomy
- No indication for boost radiation
- Resection margins positive for disease or insufficient identification of the boost volume
- Indication for radiotherapy of the regional lymph nodes
- History of prior breast or thoracic radiotherapy
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 |
|---|---|---|
| Hypofractionation with simultaneous integrated boost | Radiation | Hypofractionation with SIB |
Primary outcome
Acute Skin Toxicity
Time frame: 6 months
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
4 secondary outcomes
Number of Patients treated on Protocol
Time frame: 22-29 days (16 fractions)
Acute General Toxicity
Time frame: 0 to 6 months
Quality of life Score
Time frame: 0 to 6 months
Performance
Time frame: 0 to 6 months
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 26 Aug 2021.
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.
Juergen Dunst, Prof. study chair
University Medical Center Schleswig-Holstein (UKSH)
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionation with simultaneous integrated boost in people with Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost, run by University Hospital Schleswig-Holstein at 19 sites 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 6 inclusion and 8 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 26 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 19 sites 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.
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 Skin Toxicity (time frame: 6 months). 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 26 Aug 2021.