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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Proton therapy.
RadiationPencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival (PFS)
Time from study entry until disease progression or death from any cause.
Secondary outcomes
Overall survival (OS)
Time from diagnostic biopsy until death from any cause.
Time to progression (TTP)
Time from diagnostic biopsy until objective tumor progression, not includingdeath.
Absorbed dose to organs at risk.
Will be collected from Dose Volume Histograms.
Patterns of failure.
Are failures located within or outside of the radiation field?
Sponsors and contacts
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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