NCT06883604

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
184mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Sep 2019Jun 2041

Study Start

First participant enrolled

September 1, 2019

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
16 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2041

Expected
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

5.8 years

First QC Date

March 8, 2025

Last Update Submit

March 15, 2025

Conditions

Hodgkin Lymphoma

Keywords

Proton therapy

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

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

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

Secondary Outcomes (8)

  • Overall survival (OS)

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

  • Time to progression (TTP)

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

  • Absorbed dose to organs at risk.

    Outcome will be measured at baseline.

  • Patterns of failure.

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

  • Acute adverse events.

    Outcome will be measured within 3 months.

  • +3 more secondary outcomes

Study Arms (1)

Proton therapy

EXPERIMENTAL

Stage 1-2A Hodgkin Lymphoma.

Radiation: Proton therapy.

Interventions

Proton therapy.RADIATION

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

Proton therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sahlgrenska University Hospital

Gothenburg, S-41345, Sweden

RECRUITING

Skane University Hospital

Lund, S-22242, Sweden

RECRUITING

Orebro University Hospital

Örebro, S-70185, Sweden

RECRUITING

Karolinska University Hospital

Solna, S-17176, Sweden

RECRUITING

Umea University Hospital

Umeå, S-90737, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, S-75185, Sweden

RECRUITING

Related Publications (11)

  • 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.

    PMID: 23790512BACKGROUND

  • 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.

    PMID: 25670544BACKGROUND

  • 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.

    PMID: 25754634BACKGROUND

  • 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.

    PMID: 25025999BACKGROUND

  • 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.

    PMID: 22014950BACKGROUND

  • 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.

    PMID: 22386373BACKGROUND

  • 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.

    PMID: 24928256BACKGROUND

  • 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.

    PMID: 28911093BACKGROUND

  • 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.

    PMID: 25260491BACKGROUND

  • 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.

    PMID: 25789418BACKGROUND

  • 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.

    PMID: 27332881BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Daniel Molin, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Molin, MD, PhD

CONTACT

+46186110000daniel.molin@igp.uu.se

Christina Goldkuhl, MD

CONTACT

+46313421000christina.goldkuhl@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Proton therapy, non-inferiority compared to historical cohort.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, associate professor

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 19, 2025

Study Start

September 1, 2019

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2041

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(6)