Gated Radiotherapy in Left Sided Breast Cancer Patients

NCT ID: NCT03534570

Last Updated: 2018-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Neoplasm Female Radiotherapy Side Effect Heart Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* left sided breast cancer patients treated with breast conserving surgery

Exclusion Criteria

* patients treated with mastectomy
* patients with positive lymph nodes
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Marciana Duma

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marciana Duma, M.D.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, department of Radiation oncology

Locations

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Klinikum rechts der Isar; TUM

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Marciana Duma, M.D.

Role: CONTACT

0049 4140 5063

Stephanie E. Combs, M.D. Prof.

Role: CONTACT

Facility Contacts

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Marciana Duma, M.D.

Role: primary

0049 89 4140 5063

Stephanie E Combs

Role: backup

0049 89 4140 4501

References

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Fajardo LF, Stewart JR, Cohn KE. Morphology of radiation-induced heart disease. Arch Pathol. 1968 Nov;86(5):512-9. No abstract available.

Reference Type BACKGROUND
PMID: 5681435 (View on PubMed)

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. doi: 10.1200/JCO.2004.09.109.

Reference Type BACKGROUND
PMID: 15284266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20075151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20826032 (View on PubMed)

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. doi: 10.1002/1097-0142(197606)37:63.0.co;2-s.

Reference Type BACKGROUND
PMID: 949701 (View on PubMed)

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. doi: 10.1016/0002-9149(92)91393-i.

Reference Type BACKGROUND
PMID: 1615874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21925755 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 24253182 (View on PubMed)

Darby 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.

Reference Type BACKGROUND
PMID: 23484825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23726115 (View on PubMed)

Korreman 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.

Reference Type BACKGROUND
PMID: 16905210 (View on PubMed)

Other Identifiers

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GATTUM -1

Identifier Type: -

Identifier Source: org_study_id

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