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The purpose of this study is to reduce the risk of radiation related side effects and complications by treating with radiation (protons or photons) that exposes less of normal organs to low dose radiation.
3 treatment plans will be created to deliver between a total of 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).
The patient will then receive the radiation modality with the lowest percentage of the body receiving 4 Gy (V4Gy/CGE)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Radiation Plan | Experimental |
| |
| Conventional Photon Radiation Plan | Active Comparator |
| |
| Intensity Modulated Radiation Plan | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation Plan | Radiation | Between 21-39.6 Gy/CGE to the PTV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy. | Immediately proceeding completion of each of the three treatment plans |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Survived | Overall survival as assessed with the Kaplan-Meier product limit method. | 4 years after beginning of radiation therapy |
| Percentage of Participants Who Did Not Have Disease Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradford S Hoppe, MD, MPH | 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 |
|---|---|---|---|
| 15199092 | Background | Bonadonna G, Bonfante V, Viviani S, Di Russo A, Villani F, Valagussa P. ABVD plus subtotal nodal versus involved-field radiotherapy in early-stage Hodgkin's disease: long-term results. J Clin Oncol. 2004 Jul 15;22(14):2835-41. doi: 10.1200/JCO.2004.12.170. Epub 2004 Jun 15. | |
| 11821442 | Background | Horning SJ, Hoppe RT, Breslin S, Bartlett NL, Brown BW, Rosenberg SA. Stanford V and radiotherapy for locally extensive and advanced Hodgkin's disease: mature results of a prospective clinical trial. J Clin Oncol. 2002 Feb 1;20(3):630-7. doi: 10.1200/JCO.2002.20.3.630. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Optimal Treatment Plan | Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV). The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
20 patients were enrolled. One decided to withdrawal after being enrolled, but prior to any treatment plans being performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Therapy Plan Compared to IMRT and Conventional RT | Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy. | Posted | Median | Full Range | percentage of body receiving 4 Gy | Immediately proceeding completion of each of the three treatment plans |
|
Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment.
There were 20 patients initially enrolled. One decided to not receive treatment after initial enrollment. Three had treatment plans completed (and thus contributed that data), but sought treatment elsewhere. One patient was withdrawn after treatment. There are therefore only 15 of 20 enrolled patients actually assessable for adverse events.
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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 | Superior Treatment Plan | Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV). The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia - acute grade 2 | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradford Hoppe, MD, MPH | University of Florida Proton Therapy Institute | 904-588-1800 | bhoppe@floridaproton.org |
Not provided
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Conventional Photon Radiation Plan |
| Radiation |
Between 21-39.6 Gy/CGE to the PTV |
|
| Intensity Modulated Radiation Plan | Radiation | Between 21-39.6 Gy/CGE to the PTV |
|
Disease free survival as assessed with the Kaplan-Meier product limit method
| 4 years after beginning of radiation therapy |
| 15315964 | Background | Straus DJ, Portlock CS, Qin J, Myers J, Zelenetz AD, Moskowitz C, Noy A, Goy A, Yahalom J. Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004 Dec 1;104(12):3483-9. doi: 10.1182/blood-2004-04-1311. Epub 2004 Aug 17. |
| 17035650 | Background | Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185. |
| 18722263 | Background | Constine LS, Tarbell N, Hudson MM, Schwartz C, Fisher SG, Muhs AG, Basu SK, Kun LE, Ng A, Mauch P, Sandhu A, Culakova E, Lyman G, Mendenhall N. Subsequent malignancies in children treated for Hodgkin's disease: associations with gender and radiation dose. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):24-33. doi: 10.1016/j.ijrobp.2008.04.067. |
| 12837833 | Background | van Leeuwen FE, Klokman WJ, Stovall M, Dahler EC, van't Veer MB, Noordijk EM, Crommelin MA, Aleman BM, Broeks A, Gospodarowicz M, Travis LB, Russell NS. Roles of radiation dose, chemotherapy, and hormonal factors in breast cancer following Hodgkin's disease. J Natl Cancer Inst. 2003 Jul 2;95(13):971-80. doi: 10.1093/jnci/95.13.971. |
| 12200357 | Background | Ng AK, Bernardo MV, Weller E, Backstrand K, Silver B, Marcus KC, Tarbell NJ, Stevenson MA, Friedberg JW, Mauch PM. Second malignancy after Hodgkin disease treated with radiation therapy with or without chemotherapy: long-term risks and risk factors. Blood. 2002 Sep 15;100(6):1989-96. doi: 10.1182/blood-2002-02-0634. |
| 15205202 | Background | Behringer K, Josting A, Schiller P, Eich HT, Bredenfeld H, Diehl V, Engert A; German Hodgkin Lymphoma Study Group. Solid tumors in patients treated for Hodgkin's disease: a report from the German Hodgkin Lymphoma Study Group. Ann Oncol. 2004 Jul;15(7):1079-85. doi: 10.1093/annonc/mdh273. |
| 18838714 | Background | Campbell BA, Voss N, Pickles T, Morris J, Gascoyne RD, Savage KJ, Connors JM. Involved-nodal radiation therapy as a component of combination therapy for limited-stage Hodgkin's lymphoma: a question of field size. J Clin Oncol. 2008 Nov 10;26(32):5170-4. doi: 10.1200/JCO.2007.15.1001. Epub 2008 Oct 6. |
| 16169675 | Background | Girinsky T, Pichenot C, Beaudre A, Ghalibafian M, Lefkopoulos D. Is intensity-modulated radiotherapy better than conventional radiation treatment and three-dimensional conformal radiotherapy for mediastinal masses in patients with Hodgkin's disease, and is there a role for beam orientation optimization and dose constraints assigned to virtual volumes? Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):218-26. doi: 10.1016/j.ijrobp.2005.06.004. Epub 2005 Sep 19. |
| 15850922 | Background | Goodman KA, Toner S, Hunt M, Wu EJ, Yahalom J. Intensity-modulated radiotherapy for lymphoma involving the mediastinum. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):198-206. doi: 10.1016/j.ijrobp.2004.08.048. |
| 17547777 | Background | Nieder C, Schill S, Kneschaurek P, Molls M. Influence of different treatment techniques on radiation dose to the LAD coronary artery. Radiat Oncol. 2007 Jun 5;2:20. doi: 10.1186/1748-717X-2-20. |
| 11023601 | Background | Schneider U, Lomax A, Lombriser N. Comparative risk assessment of secondary cancer incidence after treatment of Hodgkin's disease with photon and proton radiation. Radiat Res. 2000 Oct;154(4):382-8. doi: 10.1667/0033-7587(2000)154[0382:craosc]2.0.co;2. |
| 15950715 | Background | Sigurdson AJ, Ronckers CM, Mertens AC, Stovall M, Smith SA, Liu Y, Berkow RL, Hammond S, Neglia JP, Meadows AT, Sklar CA, Robison LL, Inskip PD. Primary thyroid cancer after a first tumour in childhood (the Childhood Cancer Survivor Study): a nested case-control study. Lancet. 2005 Jun 11-17;365(9476):2014-23. doi: 10.1016/S0140-6736(05)66695-0. |
| 17156873 | Background | Nieder C, Schill S, Kneschaurek P, Molls M. Comparison of three different mediastinal radiotherapy techniques in female patients: Impact on heart sparing and dose to the breasts. Radiother Oncol. 2007 Mar;82(3):301-7. doi: 10.1016/j.radonc.2006.10.015. Epub 2006 Dec 6. |
| 11830608 | Background | Travis LB, Gospodarowicz M, Curtis RE, Clarke EA, Andersson M, Glimelius B, Joensuu T, Lynch CF, van Leeuwen FE, Holowaty E, Storm H, Glimelius I, Pukkala E, Stovall M, Fraumeni JF Jr, Boice JD Jr, Gilbert E. Lung cancer following chemotherapy and radiotherapy for Hodgkin's disease. J Natl Cancer Inst. 2002 Feb 6;94(3):182-92. doi: 10.1093/jnci/94.3.182. |
| 12876089 | Background | Travis LB, Hill DA, Dores GM, Gospodarowicz M, van Leeuwen FE, Holowaty E, Glimelius B, Andersson M, Wiklund T, Lynch CF, Van't Veer MB, Glimelius I, Storm H, Pukkala E, Stovall M, Curtis R, Boice JD Jr, Gilbert E. Breast cancer following radiotherapy and chemotherapy among young women with Hodgkin disease. JAMA. 2003 Jul 23;290(4):465-75. doi: 10.1001/jama.290.4.465. |
| 10487552 | Background | Graham MV, Purdy JA, Emami B, Harms W, Bosch W, Lockett MA, Perez CA. Clinical dose-volume histogram analysis for pneumonitis after 3D treatment for non-small cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):323-9. doi: 10.1016/s0360-3016(99)00183-2. |
| 12504042 | Background | Tsujino K, Hirota S, Endo M, Obayashi K, Kotani Y, Satouchi M, Kado T, Takada Y. Predictive value of dose-volume histogram parameters for predicting radiation pneumonitis after concurrent chemoradiation for lung cancer. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):110-5. doi: 10.1016/s0360-3016(02)03807-5. |
| 11597805 | Background | Hernando ML, Marks LB, Bentel GC, Zhou SM, Hollis D, Das SK, Fan M, Munley MT, Shafman TD, Anscher MS, Lind PA. Radiation-induced pulmonary toxicity: a dose-volume histogram analysis in 201 patients with lung cancer. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):650-9. doi: 10.1016/s0360-3016(01)01685-6. |
| 8592547 | Background | Bhatia S, Robison LL, Oberlin O, Greenberg M, Bunin G, Fossati-Bellani F, Meadows AT. Breast cancer and other second neoplasms after childhood Hodgkin's disease. N Engl J Med. 1996 Mar 21;334(12):745-51. doi: 10.1056/NEJM199603213341201. |
| 15925455 | Background | Eich HT, Haverkamp U, Engert A, Kocher M, Skripnitchenko R, Brillant C, Sehlen S, Duhmke E, Diehl V, Muller RP. Biophysical analysis of the acute toxicity of radiotherapy in Hodgkin's lymphoma--a comparison between extended field and involved field radiotherapy based on the data of the German Hodgkin Study Group. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):860-5. doi: 10.1016/j.ijrobp.2005.02.053. Epub 2005 May 31. |
| 17242396 | Background | Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22. |
| Background | IRB #70-2003: Radiation Oncology Outcome Tracking Project (RADTRAC); PI: Robert J. Amdur. |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV |
|
|
| Secondary | Percentage of Participants Who Survived | Overall survival as assessed with the Kaplan-Meier product limit method. | Patients treated with the optimal dosimetric modality | Posted | Number | 95% Confidence Interval | percentage of participants | 4 years after beginning of radiation therapy |
|
|
|
| Secondary | Percentage of Participants Who Did Not Have Disease Progression | Disease free survival as assessed with the Kaplan-Meier product limit method | Patients treated with the optimal dosimetric modality | Posted | Number | 95% Confidence Interval | percentage of participants | 4 years after beginning of radiation therapy |
|
|
|
| 1 |
| 15 |
| 0 |
| 15 |
| 6 |
| 15 |
| Esophagitis - acute grade 2 | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin toxicity - grade 2 | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| thyroid problem - grade 2 | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |