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.

NCT Number	NCT06883604
Lead Sponsor	Uppsala University Hospital Collaborators: Sahlgrenska University Hospital, University Hospital, Umeå, Region Örebro County, Karolinska University Hospital, Skane University Hospital, University Hospital, Linkoeping, Skandion Clinic, Swedish Cancer Society
Conditions	Hodgkin Lymphoma
Enrollment	75 participants
Start Date	2019-09-01
Primary Completion	2025-06 (estimated)
Study Completion	2041-06 (estimated)
Updated on ClinicalTrials.gov	2025-03-19