Proton Therapy for Hodgkin Lymphoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hodgkin Lymphoma	Radiation: Proton Radiation Plan Radiation: Conventional Photon Radiation Plan Radiation: Intensity Modulated Radiation Plan	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Improving the Therapeutic Ratio by Using Proton Beam Radiation Therapy for Patients With Stage IA-IIIBX (Bulky/Non-bulky) Hodgkin Lymphoma Involving the Mediastinum Following Standard Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

To assess the reduction of normal tissue exposed to greater than or equal to 4 Gy/CGE with use of proton therapy compared to photon therapy. [ Time Frame: Prior to starting radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess improvement and other dosimetric endpoints [ Time Frame: Prior to starting radiation therapy ] [ Designated as safety issue: No ]
Assess disease control and survival outcomes [ Time Frame: During radiation therapy; then after radiation, every 3 months for the first year, then every 6 months for the next 4 years, then annually ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2009
Estimated Study Completion Date:	July 2020
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Proton Radiation Plan	Radiation: Proton Radiation Plan Between 21-45.6 Gy/CGE to the PTV
Active Comparator: Conventional Photon Radiation Plan	Radiation: Conventional Photon Radiation Plan Between 21-45.6 Gy/CGE to the PTV
Active Comparator: Intensity Modulated Radiation Plan	Radiation: Intensity Modulated Radiation Plan Between 21-45.6 Gy/CGE to the PTV

Detailed Description:

3 treatment plans will be created to deliver between a total of 21-45.6 Gy/CGE to the planning target volume.

Proton Plan
Conventional Plan
IMRT Plan

The patient will then receive the radiation modality with the lowest body V4Gy/CGE

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed "classic" Hodgkin lymphoma.
Completed chemotherapy.

Exclusion Criteria:

Prior radiotherapy.
Prior or concurrent cancer other than non-melanomatous skin cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850200

Contacts

Contact: Intake Coordinator

877-686-6009

Locations

United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator 877-686-6009
Principal Investigator: Bradford S Hoppe, MD, MPH

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Bradford S Hoppe, MD, MPH

University of Florida Proton Therapy Institute

More Information

Additional Information:

Contact the University of Florida Proton Therapy Institute This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2004 Jun 15.

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.

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. Epub 2004 Aug 17.

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.

Constine LS, Tarbell N, Hudson MM, et al. Subsequent malignancies in children treated for Hodgkin's disease: associations with gender and radiation dose. Int J Radiat Oncol Biol Phys 2008;72:24-33.

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.

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.

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.

Campbell BA, Voss N, Pickles T, et al. 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;26:5170-5174.

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. Epub 2005 Sep 19.

Goodman KA, Toner S, Hunt M, et al. Intensity-modulated radiotherapy for lymphoma involving the mediastinum. Int J Radiat Oncol Biol Phys 2005;62:198-206.

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.

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.

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.

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. Epub 2006 Dec 6.

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.

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. Erratum in: JAMA. 2003 Sep 10;290(10):1318.

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.

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.

Hernando ML, Marks LB, Bentel GC, et al. Radiation-induced pulmonary toxicity: a dose-volume histogram analysis in 201 patients with lung cancer. Int J Radiat Oncol Biol Phys 2001;51:650-659.

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.

Eich HT, Haverkamp U, Engert A, Kocher M, Skripnitchenko R, Brillant C, Sehlen S, Dühmke E, Diehl V, Müller 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. Epub 2005 May 31.

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; The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00850200 History of Changes
Other Study ID Numbers:	UFPTI 0806 - HL01
Study First Received:	February 20, 2009
Last Updated:	March 14, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Hodgkin Lymphoma, Proton Radiation

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013

Proton Therapy for Hodgkin Lymphoma (HL01)