Breast Neoplasm FemaleGATTUMNCT03534570
Gated Radiotherapy in Left Sided Breast Cancer Patients
An observational study of Breast Neoplasm Female and Radiotherapy Side Effect, run by Technical University of Munich at 1 site in Germany.
Trial summary
To assess the need of respiratory gated radiotherapy in left sided breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Neoplasm Female, Radiotherapy Side Effect, Heart Diseases
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- May 2018to Dec 2019
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: left sided breast cancer patients
Who may be able to join
- left sided breast cancer patients treated with breast conserving surgery
Who cannot join
- patients treated with mastectomy
- patients with positive lymph nodes
Trial locations and contacts
1 site in 1 country.
Stephanie E. Combs, M.D. Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar; TUM
Munich, 81675
Marciana Duma, M.D., 0049 89 4140 5063, marciana.duma@mri.tum.de
Stephanie E Combs, 0049 89 4140 4501, stephanie.combs@tum.de
About this study
Official title: A Prospective Study on the Need of Gated (GAT) Radiotherapy in Left Sided Breast Cancer Patients Treated at the Technical University Munich (TUM) - the GATTUM Protocol
To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.
- Medical subject headings
- Radiation Injuries, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of distance from chestwall to the heart
Rigid and non-rigid measurement of distance from chestwall to the heart.
Measured: 3 years
Measurement of distance from the heart to the mammary gland
Rigid and non-rigid measurement of distance from the heart to the mammary gland
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study startMay 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marciana Duma, Technical University of Munich
- Investigators
- Marciana Duma, M.D., Principal investigator, Klinikum rechts der Isar, department of Radiation oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534570
- Sponsor's protocol ID
- GATTUM -1
- Acronym
- GATTUM
- Status last verified
- May 2018
- First submitted
- 3 Aug 2015
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fajardo LF, Stewart JR, Cohn KE. Morphology of radiation-induced heart disease. Arch Pathol. 1968 Nov;86(5):512-9. No abstract available.
PubMed 5681435Adams MJ, Lipsitz SR, Colan SD, Tarbell NJ, Treves ST, Diller L, Greenbaum N, Mauch P, Lipshultz SE. Cardiovascular status in long-term survivors of Hodgkin's disease treated with chest radiotherapy. J Clin Oncol. 2004 Aug 1;22(15):3139-48. doi: 10.1200/JCO.2004.09.109.
PubMed 15284266Shimizu Y, Kodama K, Nishi N, Kasagi F, Suyama A, Soda M, Grant EJ, Sugiyama H, Sakata R, Moriwaki H, Hayashi M, Konda M, Shore RE. Radiation exposure and circulatory disease risk: Hiroshima and Nagasaki atomic bomb survivor data, 1950-2003. BMJ. 2010 Jan 14;340:b5349. doi: 10.1136/bmj.b5349.
PubMed 20075151Andratschke N, Maurer J, Molls M, Trott KR. Late radiation-induced heart disease after radiotherapy. Clinical importance, radiobiological mechanisms and strategies of prevention. Radiother Oncol. 2011 Aug;100(2):160-6. doi: 10.1016/j.radonc.2010.08.010. Epub 2010 Sep 7.
PubMed 20826032Carmel RJ, Kaplan HS. Mantle irradiation in Hodgkin's disease. An analysis of technique, tumor eradication, and complications. Cancer. 1976 Jun;37(6):2813-25. doi: 10.1002/1097-0142(197606)37:63.0.co;2-s.
PubMed 949701Larsen RL, Jakacki RI, Vetter VL, Meadows AT, Silber JH, Barber G. Electrocardiographic changes and arrhythmias after cancer therapy in children and young adults. Am J Cardiol. 1992 Jul 1;70(1):73-7. doi: 10.1016/0002-9149(92)91393-i.
PubMed 1615874Cella L, Liuzzi R, Conson M, Torre G, Caterino M, De Rosa N, Picardi M, Camera L, Solla R, Farella A, Salvatore M, Pacelli R. Dosimetric predictors of asymptomatic heart valvular dysfunction following mediastinal irradiation for Hodgkin's lymphoma. Radiother Oncol. 2011 Nov;101(2):316-21. doi: 10.1016/j.radonc.2011.08.040. Epub 2011 Sep 16.
PubMed 21925755Duma MN, Molls M, Trott KR. From heart to heart for breast cancer patients - cardiovascular toxicities in breast cancer radiotherapy. Strahlenther Onkol. 2014 Jan;190(1):5-7. doi: 10.1007/s00066-013-0465-4. Epub 2013 Nov 21. No abstract available.
PubMed 24253182Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.
PubMed 23484825Bartlett FR, Colgan RM, Carr K, Donovan EM, McNair HA, Locke I, Evans PM, Haviland JS, Yarnold JR, Kirby AM. The UK HeartSpare Study: randomised evaluation of voluntary deep-inspiratory breath-hold in women undergoing breast radiotherapy. Radiother Oncol. 2013 Aug;108(2):242-7. doi: 10.1016/j.radonc.2013.04.021. Epub 2013 May 29.
PubMed 23726115Korreman SS, Pedersen AN, Josipovic M, Aarup LR, Juhler-Nottrup T, Specht L, Nystrom H. Cardiac and pulmonary complication probabilities for breast cancer patients after routine end-inspiration gated radiotherapy. Radiother Oncol. 2006 Aug;80(2):257-62. doi: 10.1016/j.radonc.2006.07.020. Epub 2006 Aug 14.
PubMed 16905210
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Need of Gated (GAT) Radiotherapy in Left Sided Breast Cancer Patients Treated at the Technical University Munich (TUM) - the GATTUM Protocol
- ClinicalTrials.gov ID
- NCT03534570
- Acronym / sponsor ID
- GATTUM / GATTUM -1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 May 2018 (actual)
- 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.
To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- left sided breast cancer patients
Key inclusion criteria (1 listed)
- left sided breast cancer patients treated with breast conserving surgery
Key exclusion criteria (2 listed)
- patients treated with mastectomy
- patients with positive lymph nodes
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
Measurement of distance from chestwall to the heart
Time frame: 3 years
Rigid and non-rigid measurement of distance from chestwall to the heart.
Measurement of distance from the heart to the mammary gland
Time frame: 3 years
Rigid and non-rigid measurement of distance from the heart to the mammary gland
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Background: PubMed 5681435Fajardo LF, Stewart JR, Cohn KE. Morphology of radiation-induced heart disease. Arch Pathol. 1968 Nov;86(5):512-9. No abstract available.
- Background: PubMed 15284266Adams MJ, Lipsitz SR, Colan SD, Tarbell NJ, Treves ST, Diller L, Greenbaum N, Mauch P, Lipshultz SE. Cardiovascular status in long-term survivors of Hodgkin's disease treated with chest radiotherapy. J Clin Oncol. 2004 Aug 1;22(15):3139-48. doi: 10.1200/JCO.2004.09.109.
- Background: PubMed 20075151Shimizu Y, Kodama K, Nishi N, Kasagi F, Suyama A, Soda M, Grant EJ, Sugiyama H, Sakata R, Moriwaki H, Hayashi M, Konda M, Shore RE. Radiation exposure and circulatory disease risk: Hiroshima and Nagasaki atomic bomb survivor data, 1950-2003. BMJ. 2010 Jan 14;340:b5349. doi: 10.1136/bmj.b5349.
- Background: PubMed 20826032Andratschke N, Maurer J, Molls M, Trott KR. Late radiation-induced heart disease after radiotherapy. Clinical importance, radiobiological mechanisms and strategies of prevention. Radiother Oncol. 2011 Aug;100(2):160-6. doi: 10.1016/j.radonc.2010.08.010. Epub 2010 Sep 7.
- Background: PubMed 949701Carmel RJ, Kaplan HS. Mantle irradiation in Hodgkin's disease. An analysis of technique, tumor eradication, and complications. Cancer. 1976 Jun;37(6):2813-25. doi: 10.1002/1097-0142(197606)37:63.0.co;2-s.
- Background: PubMed 1615874Larsen RL, Jakacki RI, Vetter VL, Meadows AT, Silber JH, Barber G. Electrocardiographic changes and arrhythmias after cancer therapy in children and young adults. Am J Cardiol. 1992 Jul 1;70(1):73-7. doi: 10.1016/0002-9149(92)91393-i.
- Background: PubMed 21925755Cella L, Liuzzi R, Conson M, Torre G, Caterino M, De Rosa N, Picardi M, Camera L, Solla R, Farella A, Salvatore M, Pacelli R. Dosimetric predictors of asymptomatic heart valvular dysfunction following mediastinal irradiation for Hodgkin's lymphoma. Radiother Oncol. 2011 Nov;101(2):316-21. doi: 10.1016/j.radonc.2011.08.040. Epub 2011 Sep 16.
- Background: PubMed 24253182Duma MN, Molls M, Trott KR. From heart to heart for breast cancer patients - cardiovascular toxicities in breast cancer radiotherapy. Strahlenther Onkol. 2014 Jan;190(1):5-7. doi: 10.1007/s00066-013-0465-4. Epub 2013 Nov 21. No abstract available.
- Background: PubMed 23484825Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.
- Background: PubMed 23726115Bartlett FR, Colgan RM, Carr K, Donovan EM, McNair HA, Locke I, Evans PM, Haviland JS, Yarnold JR, Kirby AM. The UK HeartSpare Study: randomised evaluation of voluntary deep-inspiratory breath-hold in women undergoing breast radiotherapy. Radiother Oncol. 2013 Aug;108(2):242-7. doi: 10.1016/j.radonc.2013.04.021. Epub 2013 May 29.
- Background: PubMed 16905210Korreman SS, Pedersen AN, Josipovic M, Aarup LR, Juhler-Nottrup T, Specht L, Nystrom H. Cardiac and pulmonary complication probabilities for breast cancer patients after routine end-inspiration gated radiotherapy. Radiother Oncol. 2006 Aug;80(2):257-62. doi: 10.1016/j.radonc.2006.07.020. Epub 2006 Aug 14.
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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.
Stephanie E. Combs, M.D. Prof. contact
Marciana Duma, M.D. principal investigator
Klinikum rechts der Isar, department of Radiation oncology
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 Neoplasm Female and Radiotherapy Side Effect, run by Technical University of Munich 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 1 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 23 May 2018. 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.
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?
Contact Marciana Duma, M.D. (0049 4140 5063, Marciana.Duma@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of distance from chestwall to the heart (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT03534570, which also lists 11 linked publications.
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 23 May 2018.