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| ID | Type | Description | Link |
|---|---|---|---|
| UFPTI 1016-BR01 | Other Identifier | University of Florida Project # |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Conventional photon plan |
|
| 2 | Experimental | 3D-Proton/Conventional plan or 3D-proton only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon | Radiation | 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Dosimetric Endpoint | Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax. | 2 weeks prior to starting radiation therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Bradley, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18287387 | Background | 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. | |
| 16360786 | Background | 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. |
| Label | URL |
|---|---|
| University of Florida Proton Therapy Institute website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Phase | During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient. |
| FG001 | Conventional Photon Plan | Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment. |
| FG002 | 3D-Proton/Conventional Plan or 3D-proton Only | 3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Phase |
| |||||||||||||
| Treatment Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Patients Planned With Both Proton & Conventional Plans | Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment. Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | % of heart receiving >= 5 Gray (Gy) | 2 weeks prior to starting radiation therapy. |
|
From start of radiation therapy to date of last follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Patients Planned With Both Proton & Conventional Plans | All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional. Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment. Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | All patients ultimately treated under the proton plan, so the denominator for this event refers exclusively to the proton arm and not conventional. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast atrophy | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Bradley | University of Florida Proton Therapy Institute | 904-588-1800 | jbradley@floridaproton.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017785 | Photons |
| ID | Term |
|---|---|
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
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| 3D-Proton/Conventional plan or 3D-proton only |
| Radiation |
50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction |
|
| Assessment of Acute Side Effects | Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea. | 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. | Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies. Analyze local control, progression-free survival, and overall survival. | 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter. |
| Assessment of Cardiac Function Markers | Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment. | after treatment |
| 9395428 | Background | 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. |
| 10335782 | Background | 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. |
| 9309100 | Background | 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. |
| 18684584 | Background | 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. |
| 15465187 | Background | 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. |
| 13839973 | Background | TURNER-WARWICK RT. The lymphatics of the breast. Br J Surg. 1959 May;46:574-82. doi: 10.1002/bjs.18004620004. No abstract available. |
| 18723148 | Background | 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. |
| 18467318 | Background | 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. |
| 10705000 | Background | 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. |
| 10658521 | Background | 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. |
| 3363169 | Background | 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. |
| 8120544 | Background | 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. |
| 10543669 | Background | 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. |
| 16054566 | Background | 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. |
| 9336133 | Background | 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. |
| 17350177 | Background | 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. |
| 9747813 | Background | 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. |
| 11777631 | Background | 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. |
| 11955730 | Background | 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. |
| Background | 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. |
| NOT COMPLETED |
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| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Secondary Dosimetric Endpoint | Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax. | Not Posted | 2 weeks prior to starting radiation therapy. | Participants |
| Secondary | Assessment of Acute Side Effects | Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea. | Not Posted | Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks. | Participants |
| Secondary | Assessment of Longterm Side Effects and Disease Specific End Points. | Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies. Analyze local control, progression-free survival, and overall survival. | Not Posted | 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter. | Participants |
| Secondary | Assessment of Cardiac Function Markers | Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment. | Not Posted | after treatment | Participants |
| 6 |
| 18 |
| 11 |
| 18 |
|
| Radiation dermatitis | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | All patients ultimately treated under the proton plan, so the denominator for this event refers exclusively to the proton arm and not conventional. |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphedema | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D055590 |
| Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |