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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUppsala University Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Proton therapy.

Treatment groups

75 Participants
are divided into 1 treatment group

Sponsors and collaborators

Uppsala University Hospital

Lead sponsor

Sahlgrenska University Hospital

Collaborator

University Hospital, Umeå

Collaborator

Region Örebro County

Collaborator

Karolinska University Hospital

Collaborator

Skane University Hospital

Collaborator

University Hospital, Linkoeping

Collaborator

Skandion Clinic

Collaborator

Swedish Cancer Society

Collaborator