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Hodgkin LymphomaPRO-HodgkinNCT06883604

Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

A study testing Proton therapy. in people with Hodgkin Lymphoma, run by Uppsala University Hospital at 6 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Proton therapy.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
6 sitesSweden
Study dates
1 Sep 2019to Jun 2041
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Histological diagnosis of classic Hodgkin Lymphoma.
  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • Pregnancy.
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Molin, MD, PhD contact

+46186110000

daniel.molin@igp.uu.se

Christina Goldkuhl, MD contact

+46313421000

christina.goldkuhl@vgregion.se

6 sites in 1 country

Sweden6 sites, 6 recruiting
  • Sahlgrenska University Hospital

    Gothenburg, S-41345

    Christina Goldkuhl, MD

    Recruiting
  • Skane University Hospital

    Lund, S-22242

    Johan Linderoth, MD, Phd

    Recruiting
  • Orebro University Hospital

    Örebro, S-70185

    Jenny Kahlmeter Brandell

    Recruiting
  • Karolinska University Hospital

    Solna, S-17176

    Marzia Palma, MD, PhD

    Lotta Hansson

    Recruiting
  • Umea University Hospital

    Umeå, S-90737

    Ann-Sofie Johansson, MD, PhD

    Recruiting
  • Uppsala University Hospital

    Uppsala, S-75185

    Daniel Molin, MD, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. With proton therapy the dose to normal tissue can be minimised without compromising the dose to the tumor. The aim of our study is to investigate whether proton therapy can be delivered in a safe way to Hodgkin Lymphoma patients with less late side effects than conventional radiotherapy, while retaining the high cure rate.

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.

Being tested
Proton therapy.
Keywords
Proton therapy
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton therapy.Radiation

    Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).

Study groups in NCT06883604
Study groupRoleWhat they receive
Proton therapyExperimentalStage 1-2A Hodgkin Lymphoma.
Receives: Radiation: Proton therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Time from study entry until disease progression or death from any cause.

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

Secondary outcomes (8)
  1. Overall survival (OS)

    Time from diagnostic biopsy until death from any cause.

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

  2. Time to progression (TTP)

    Time from diagnostic biopsy until objective tumor progression, not includingdeath.

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

  3. Absorbed dose to organs at risk.

    Will be collected from Dose Volume Histograms.

    Measured: Outcome will be measured at baseline.

  4. Patterns of failure.

    Are failures located within or outside of the radiation field?

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

  5. Acute adverse events.

    The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy.

    Measured: Outcome will be measured within 3 months.

  6. Long-term adverse events.

    This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later.

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

  7. Quality of life.

    EORTC quality of life questionnaire (QLQ)-C30.

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

  8. Quality of life.

    EORTC quality of life questionnaire (QLQ)-Hodgkin lymphoma (HL)27.

    Measured: Outcome will be measured after 1, 3, 5 and 16 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start1 Sep 2019
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Proton therapy, non-inferiority compared to historical cohort.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06883604
Sponsor's protocol ID
2019-00010
Other IDs
2019
Acronym
PRO-Hodgkin
Status last verified
Mar 2025
First submitted
8 Mar 2025
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23790512
  • 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.

    PubMed 25670544
  • 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.

    PubMed 25754634
  • 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.

    PubMed 25025999
  • 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.

    PubMed 22014950
  • 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.

    PubMed 22386373
  • 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.

    PubMed 24928256
  • 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.

    PubMed 28911093
  • 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.

    PubMed 25260491
  • 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.

    PubMed 25789418
  • 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.

    PubMed 27332881

Questions about this trial

What is this clinical trial studying?

A study testing Proton therapy. in people with Hodgkin Lymphoma, run by Uppsala University Hospital at 6 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Molin, MD, PhD (+46186110000, daniel.molin@igp.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: Outcome will be measured after 1, 3, 5 and 16 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06883604, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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