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RECRUITING
NCT06883604
NA

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

Sponsor: Uppsala University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2019-09-01

Completion Date

2041-06

Last Updated

2025-03-19

Healthy Volunteers

No

Interventions

RADIATION

Proton therapy.

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

Locations (6)

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Lund, Sweden

Orebro University Hospital

Örebro, Sweden

Karolinska University Hospital

Solna, Sweden

Umea University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden