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NCT Number: NCT06883604

Clinical Investigation of 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.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.

Treatment and study plan

Proton therapy.

Radiation

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

Primary outcomes

  1. Progression free survival (PFS)

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

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

Secondary outcomes

  1. Overall survival (OS)

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

    Time from diagnostic biopsy until death from any cause.

  2. Time to progression (TTP)

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

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

  3. Absorbed dose to organs at risk.

    Time frame: Outcome will be measured at baseline.

    Will be collected from Dose Volume Histograms.

  4. Patterns of failure.

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

    Are failures located within or outside of the radiation field?

  5. Acute adverse events.

    Time frame: Outcome will be measured within 3 months.

    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.

  6. Long-term adverse events.

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

    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.

  7. Quality of life.

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

    EORTC quality of life questionnaire (QLQ)-C30.

  8. Quality of life.

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Goldkuhl, MD

CONTACT

[email protected]

+46313421000

Daniel Molin, MD, PhD

CONTACT

[email protected]

+46186110000

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Karolinska University Hospital
  • Region Örebro County
  • Sahlgrenska University Hospital
  • Skandion Clinic
  • Skane University Hospital
  • Swedish Cancer Society
  • University Hospital, Linkoeping
  • University Hospital, Umeå

Registry information

Official study title

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

Acronym: PRO-Hodgkin

Important dates

Study start
2019
Primary completion
2025
Study completion
2041
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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