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

Last updated: March 15, 2025
Sponsor: Uppsala University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Platelet Disorders

Marginal Zone Lymphoma

Treatment

Proton therapy.

Clinical Study ID

NCT06883604
2019-00010
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, erythrocytesedimentation 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 factorsand 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 issufficient 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 studytreatment period.

Exclusion

Exclusion Criteria:

  • Pregnancy.

  • Serious concomitant systemic disorder endangering treatment delivery.

  • More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deepinspiration breath hold (DIBH) is used. Not applicable if target is located outsidemediastinum or photon treatment is planned.

  • Clinical or radiographic stable disease (SD)/ progressive disease (PD) duringinduction chemotherapy.

  • Not able to comply with treatment and study procedures.

  • No additional active malignancy except indolent lymphoma in the bone marrow, basalcell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervicalcancer.

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: Proton therapy.
Phase:
Study Start date:
September 01, 2019
Estimated Completion Date:
June 30, 2041

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg, S-41345
    Sweden

    Active - Recruiting

  • Skane University Hospital

    Lund, S-22242
    Sweden

    Active - Recruiting

  • Orebro University Hospital

    Orebro, S-70185
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Solna, S-17176
    Sweden

    Active - Recruiting

  • Umea University Hospital

    Umea, S-90737
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala, S-75185
    Sweden

    Active - Recruiting

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