Gated Radiotherapy in Left Sided Breast Cancer Patients

Heart Diseases Clinical Trial

— GATTUM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03534570
• Other study ID #: GATTUM -1
• Status: Recruiting
• Start date: May 2018
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Technische Universität München
• Contact: Marciana Duma, M.D.
• Phone: 0049 4140 5063
• Email: Marciana.Duma[@]mri.tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• left sided breast cancer patients treated with breast conserving surgery

Exclusion Criteria:

• patients treated with mastectomy

• patients with positive lymph nodes

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Heart Diseases
• Radiotherapy Side Effect

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar; TUM	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (11)

Adams 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. — View Citation

Andratschke 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. Review. — View Citation

Bartlett 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. — View Citation

Carmel RJ, Kaplan HS. Mantle irradiation in Hodgkin's disease. An analysis of technique, tumor eradication, and complications. Cancer. 1976 Jun;37(6):2813-25. — View Citation

Cella 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. — View Citation

Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Brønnum 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. — View Citation

Duma 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. — View Citation

Fajardo LF, Stewart JR, Cohn KE. Morphology of radiation-induced heart disease. Arch Pathol. 1968 Nov;86(5):512-9. — View Citation

Korreman SS, Pedersen AN, Josipovic M, Aarup LR, Juhler-Nøttrup T, Specht L, Nyström H. Cardiac and pulmonary complication probabilities for breast cancer patients after routine end-inspiration gated radiotherapy. Radiother Oncol. 2006 Aug;80(2):257-62. Epub 2006 Aug 14. — View Citation

Larsen 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. — View Citation

Shimizu 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of distance from chestwall to the heart	Rigid and non-rigid measurement of distance from chestwall to the heart.	3 years
Primary	Measurement of distance from the heart to the mammary gland	Rigid and non-rigid measurement of distance from the heart to the mammary gland	3 years