Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
NCT ID: NCT06883604
Last Updated: 2025-03-19
Study Results
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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RECRUITING
NA
75 participants
INTERVENTIONAL
2019-09-01
2041-06-30
Brief Summary
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This is a multicentre phase II study of PBS proton beam therapy in patients ≤60 years, with early stage Hodgkin Lymphoma treated with induction chemotherapy. The study is performed in a non-inferiority setting comparing with a historical population-based consecutive Swedish material. The control group was treated according to the same principles, except that the radiotherapy was delivered with photons.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Proton therapy
Stage 1-2A Hodgkin Lymphoma.
Proton therapy.
Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
Interventions
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Proton therapy.
Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
Eligibility Criteria
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Inclusion Criteria
* Ann Arbour stage 1A, 1B or 2A.
* Both patients with and without risk factors, i.e. bulky disease, erythrocyte sedimentation rate (ESR)\>50, more than two involved sites.
* Supra diaphragmal disease.
* Age 18-60 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
* Initial staging positron emission tomography/computed tomography (PET/CT).
* Induction chemotherapy including 2 cycles of ABVD for patients without risk factors and 4 cycles of ABVD for patients with risk factors.
* For patients with risk factors a CT after 2 ABVD confirming complete remission (CR) or partial remission (PR). For patients without risk factors clinical response is sufficient at inclusion, but a CT scan is recommended before start of radiotherapy.
* Radiotherapy (RT) start not later than 6 weeks after end of chemotherapy.
* Written informed consent obtained prior to any study specific procedures.
* Women of reproductive age must agree to use contraceptives during the study treatment period.
Exclusion Criteria
* Serious concomitant systemic disorder endangering treatment delivery.
* More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deep inspiration breath hold (DIBH) is used. Not applicable if target is located outside mediastinum or photon treatment is planned.
* Clinical or radiographic stable disease (SD)/ progressive disease (PD) during induction chemotherapy.
* Not able to comply with treatment and study procedures.
* No additional active malignancy except indolent lymphoma in the bone marrow, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.
18 Years
60 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
University Hospital of Umeå
UNKNOWN
Region Örebro County
OTHER
Karolinska University Hospital
OTHER
Skane University Hospital
OTHER
University Hospital, Linkoeping
OTHER
Skandion Clinic
UNKNOWN
Swedish Cancer Society
OTHER
Uppsala University Hospital
OTHER
Responsible Party
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Daniel Molin
MD, PhD, associate professor
Principal Investigators
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Daniel Molin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Skane University Hospital
Lund, , Sweden
Orebro University Hospital
Örebro, , Sweden
Karolinska University Hospital
Solna, , Sweden
Umea University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Christina Goldkuhl, MD
Role: primary
Johan Linderoth, MD, Phd
Role: primary
Jenny Kahlmeter Brandell
Role: primary
Marzia Palma, MD, PhD
Role: primary
Ann-Sofie Johansson, MD, PhD
Role: primary
Daniel Molin, MD, PhD
Role: primary
References
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Specht L, Yahalom J, Illidge T, Berthelsen AK, Constine LS, Eich HT, Girinsky T, Hoppe RT, Mauch P, Mikhaeel NG, Ng A; ILROG. Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the international lymphoma radiation oncology group (ILROG). Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):854-62. doi: 10.1016/j.ijrobp.2013.05.005. Epub 2013 Jun 18.
Maraldo MV, Dabaja BS, Filippi AR, Illidge T, Tsang R, Ricardi U, Petersen PM, Schut DA, Garcia J, Headley J, Parent A, Guibord B, Ragona R, Specht L. Radiation therapy planning for early-stage Hodgkin lymphoma: experience of the International Lymphoma Radiation Oncology Group. Int J Radiat Oncol Biol Phys. 2015 May 1;92(1):144-52. doi: 10.1016/j.ijrobp.2014.12.009. Epub 2015 Feb 7.
Aznar MC, Maraldo MV, Schut DA, Lundemann M, Brodin NP, Vogelius IR, Berthelsen AK, Specht L, Petersen PM. Minimizing late effects for patients with mediastinal Hodgkin lymphoma: deep inspiration breath-hold, IMRT, or both? Int J Radiat Oncol Biol Phys. 2015 May 1;92(1):169-74. doi: 10.1016/j.ijrobp.2015.01.013. Epub 2015 Mar 5.
Petersen PM, Aznar MC, Berthelsen AK, Loft A, Schut DA, Maraldo M, Josipovic M, Klausen TL, Andersen FL, Specht L. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma: benefit of deep inspiration breath-hold. Acta Oncol. 2015 Jan;54(1):60-6. doi: 10.3109/0284186X.2014.932435. Epub 2014 Jul 15.
Hoppe BS, Flampouri S, Su Z, Morris CG, Latif N, Dang NH, Lynch J, Li Z, Mendenhall NP. Consolidative involved-node proton therapy for Stage IA-IIIB mediastinal Hodgkin lymphoma: preliminary dosimetric outcomes from a Phase II study. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):260-7. doi: 10.1016/j.ijrobp.2011.06.1959. Epub 2011 Oct 17.
Hoppe BS, Flampouri S, Su Z, Latif N, Dang NH, Lynch J, Joyce M, Sandler E, Li Z, Mendenhall NP. Effective dose reduction to cardiac structures using protons compared with 3DCRT and IMRT in mediastinal Hodgkin lymphoma. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):449-55. doi: 10.1016/j.ijrobp.2011.12.034. Epub 2012 Mar 2.
Hoppe BS, Flampouri S, Zaiden R, Slayton W, Sandler E, Ozdemir S, Dang NH, Lynch JW, Li Z, Morris CG, Mendenhall NP. Involved-node proton therapy in combined modality therapy for Hodgkin lymphoma: results of a phase 2 study. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1053-1059. doi: 10.1016/j.ijrobp.2014.04.029. Epub 2014 Jun 10.
Hoppe BS, Hill-Kayser CE, Tseng YD, Flampouri S, Elmongy HM, Cahlon O, Mendenhall NP, Maity A, McGee LA, Plastaras JP. Consolidative proton therapy after chemotherapy for patients with Hodgkin lymphoma. Ann Oncol. 2017 Sep 1;28(9):2179-2184. doi: 10.1093/annonc/mdx287.
Chang JY, Li H, Zhu XR, Liao Z, Zhao L, Liu A, Li Y, Sahoo N, Poenisch F, Gomez DR, Wu R, Gillin M, Zhang X. Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):809-18. doi: 10.1016/j.ijrobp.2014.07.045. Epub 2014 Sep 24.
Zeng C, Plastaras JP, Tochner ZA, White BM, Hill-Kayser CE, Hahn SM, Both S. Proton pencil beam scanning for mediastinal lymphoma: the impact of interplay between target motion and beam scanning. Phys Med Biol. 2015 Apr 7;60(7):3013-29. doi: 10.1088/0031-9155/60/7/3013. Epub 2015 Mar 19.
Zeng C, Plastaras JP, James P, Tochner ZA, Hill-Kayser CE, Hahn SM, Both S. Proton pencil beam scanning for mediastinal lymphoma: treatment planning and robustness assessment. Acta Oncol. 2016 Sep-Oct;55(9-10):1132-1138. doi: 10.1080/0284186X.2016.1191665. Epub 2016 Jun 22.
Other Identifiers
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2019-00010
Identifier Type: -
Identifier Source: org_study_id
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