NCT01365845

Brief Summary

The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 5, 2014

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2018

Completed
Last Updated

June 29, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

May 19, 2011

Results QC Date

September 11, 2014

Last Update Submit

May 24, 2018

Conditions

Breast Cancer

Keywords

Proton RadiationBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)

    A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.

    2 weeks prior to starting radiation therapy.

Secondary Outcomes (4)

  • Secondary Dosimetric Endpoint

    2 weeks prior to starting radiation therapy.

  • Assessment of Acute Side Effects

    Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.

  • Assessment of Longterm Side Effects and Disease Specific End Points.

    1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.

  • Assessment of Cardiac Function Markers

    after treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Conventional photon plan

Radiation: Photon

2

EXPERIMENTAL

3D-Proton/Conventional plan or 3D-proton only

Radiation: 3D-Proton/Conventional plan or 3D-proton only

Interventions

PhotonRADIATION

50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction

1
3D-Proton/Conventional plan or 3D-proton onlyRADIATION

50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction

2

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
  • Patients must have undergone either mastectomy or breast conservation surgery.
  • Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
  • Patient must require peripheral lymph node radiation per physician discretion.

You may not qualify if:

  • Evidence of distant metastasis (M1).
  • Prior radiotherapy to the area of interest.
  • Prior history of cardiovascular disease per physician discretion.
  • Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
  • Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (22)

  • Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

    PMID: 18287387BACKGROUND

  • Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

    PMID: 16360786BACKGROUND

  • Overgaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, Kjaer M, Gadeberg CC, Mouridsen HT, Jensen MB, Zedeler K. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997 Oct 2;337(14):949-55. doi: 10.1056/NEJM199710023371401.

    PMID: 9395428BACKGROUND

  • Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, Kamby C, Kjaer M, Gadeberg CC, Rasmussen BB, Blichert-Toft M, Mouridsen HT. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999 May 15;353(9165):1641-8. doi: 10.1016/S0140-6736(98)09201-0.

    PMID: 10335782BACKGROUND

  • Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, Wilson KS, Knowling MA, Coppin CM, Paradis M, Coldman AJ, Olivotto IA. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997 Oct 2;337(14):956-62. doi: 10.1056/NEJM199710023371402.

    PMID: 9309100BACKGROUND

  • Heuts EM, van der Ent FW, von Meyenfeldt MF, Voogd AC. Internal mammary lymph drainage and sentinel node biopsy in breast cancer - A study on 1008 patients. Eur J Surg Oncol. 2009 Mar;35(3):252-7. doi: 10.1016/j.ejso.2008.06.1493. Epub 2008 Aug 5.

    PMID: 18684584BACKGROUND

  • Farrus B, Vidal-Sicart S, Velasco M, Zanon G, Fernandez PL, Munoz M, Santamaria G, Albanell J, Biete A. Incidence of internal mammary node metastases after a sentinel lymph node technique in breast cancer and its implication in the radiotherapy plan. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):715-21. doi: 10.1016/j.ijrobp.2004.04.021.

    PMID: 15465187BACKGROUND

  • TURNER-WARWICK RT. The lymphatics of the breast. Br J Surg. 1959 May;46:574-82. doi: 10.1002/bjs.18004620004. No abstract available.

    PMID: 13839973BACKGROUND

  • Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.

    PMID: 18723148BACKGROUND

  • Veronesi U, Arnone P, Veronesi P, Galimberti V, Luini A, Rotmensz N, Botteri E, Ivaldi GB, Leonardi MC, Viale G, Sagona A, Paganelli G, Panzeri R, Orecchia R. The value of radiotherapy on metastatic internal mammary nodes in breast cancer. Results on a large series. Ann Oncol. 2008 Sep;19(9):1553-60. doi: 10.1093/annonc/mdn183. Epub 2008 May 7.

    PMID: 18467318BACKGROUND

  • Freedman GM, Fowble BL, Nicolaou N, Sigurdson ER, Torosian MH, Boraas MC, Hoffman JP. Should internal mammary lymph nodes in breast cancer be a target for the radiation oncologist? Int J Radiat Oncol Biol Phys. 2000 Mar 1;46(4):805-14. doi: 10.1016/s0360-3016(99)00481-2.

    PMID: 10705000BACKGROUND

  • Veronesi U, Marubini E, Mariani L, Valagussa P, Zucali R. The dissection of internal mammary nodes does not improve the survival of breast cancer patients. 30-year results of a randomised trial. Eur J Cancer. 1999 Sep;35(9):1320-5. doi: 10.1016/s0959-8049(99)00133-1.

    PMID: 10658521BACKGROUND

  • Arriagada R, Le MG, Mouriesse H, Fontaine F, Dewar J, Rochard F, Spielmann M, Lacour J, Tubiana M, Sarrazin D. Long-term effect of internal mammary chain treatment. Results of a multivariate analysis of 1195 patients with operable breast cancer and positive axillary nodes. Radiother Oncol. 1988 Mar;11(3):213-22. doi: 10.1016/0167-8140(88)90003-5.

    PMID: 3363169BACKGROUND

  • Cuzick J, Stewart H, Rutqvist L, Houghton J, Edwards R, Redmond C, Peto R, Baum M, Fisher B, Host H, et al. Cause-specific mortality in long-term survivors of breast cancer who participated in trials of radiotherapy. J Clin Oncol. 1994 Mar;12(3):447-53. doi: 10.1200/JCO.1994.12.3.447.

    PMID: 8120544BACKGROUND

  • Hojris I, Overgaard M, Christensen JJ, Overgaard J. Morbidity and mortality of ischaemic heart disease in high-risk breast-cancer patients after adjuvant postmastectomy systemic treatment with or without radiotherapy: analysis of DBCG 82b and 82c randomised trials. Radiotherapy Committee of the Danish Breast Cancer Cooperative Group. Lancet. 1999 Oct 23;354(9188):1425-30. doi: 10.1016/s0140-6736(99)02245-x.

    PMID: 10543669BACKGROUND

  • Darby SC, McGale P, Taylor CW, Peto R. Long-term mortality from heart disease and lung cancer after radiotherapy for early breast cancer: prospective cohort study of about 300,000 women in US SEER cancer registries. Lancet Oncol. 2005 Aug;6(8):557-65. doi: 10.1016/S1470-2045(05)70251-5.

    PMID: 16054566BACKGROUND

  • Marks LB, Munley MT, Bentel GC, Zhou SM, Hollis D, Scarfone C, Sibley GS, Kong FM, Jirtle R, Jaszczak R, Coleman RE, Tapson V, Anscher M. Physical and biological predictors of changes in whole-lung function following thoracic irradiation. Int J Radiat Oncol Biol Phys. 1997 Oct 1;39(3):563-70. doi: 10.1016/s0360-3016(97)00343-x.

    PMID: 9336133BACKGROUND

  • Kahan Z, Csenki M, Varga Z, Szil E, Cserhati A, Balogh A, Gyulai Z, Mandi Y, Boda K, Thurzo L. The risk of early and late lung sequelae after conformal radiotherapy in breast cancer patients. Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):673-81. doi: 10.1016/j.ijrobp.2006.12.016. Epub 2007 Mar 9.

    PMID: 17350177BACKGROUND

  • Kwa SL, Lebesque JV, Theuws JC, Marks LB, Munley MT, Bentel G, Oetzel D, Spahn U, Graham MV, Drzymala RE, Purdy JA, Lichter AS, Martel MK, Ten Haken RK. Radiation pneumonitis as a function of mean lung dose: an analysis of pooled data of 540 patients. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):1-9. doi: 10.1016/s0360-3016(98)00196-5.

    PMID: 9747813BACKGROUND

  • Lind PA, Marks LB, Hardenbergh PH, Clough R, Fan M, Hollis D, Hernando ML, Lucas D, Piepgrass A, Prosnitz LR. Technical factors associated with radiation pneumonitis after local +/- regional radiation therapy for breast cancer. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):137-43. doi: 10.1016/s0360-3016(01)01715-1.

    PMID: 11777631BACKGROUND

  • Wennberg B, Gagliardi G, Sundbom L, Svane G, Lind P. Early response of lung in breast cancer irradiation: radiologic density changes measured by CT and symptomatic radiation pneumonitis. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1196-206. doi: 10.1016/s0360-3016(01)02770-5.

    PMID: 11955730BACKGROUND

  • N. Xu, M. Ho, C.G. Morris, N.P. Mendenhall. Proton treatment of peripheral lymph nodes in breast cancer. Int J Radiat Oncol Biol Phys 2010; 78: S803.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Photons

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Elementary ParticlesPhysical PhenomenaLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Results Point of Contact

Title
Dr. Julie Bradley
Organization
University of Florida Proton Therapy Institute
jbradley@floridaproton.org
904-588-1800

Study Officials

  • Julie A Bradley, MD

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2011

First Posted

June 3, 2011

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 23, 2018

Last Updated

June 29, 2018

Results First Posted

December 5, 2014

Record last verified: 2018-05

Locations

US(1)