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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Proton therapy.

    Radiation

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

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Proton therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Time from study entry until disease progression or death from any cause.

Time frame
Outcome will be measured after 1, 3, 5 and 16 years.

Secondary outcomes

1

Overall survival (OS)

Time from diagnostic biopsy until death from any cause.

Time frame
Outcome will be measured after 1, 3, 5 and 16 years.
2

Time to progression (TTP)

Time from diagnostic biopsy until objective tumor progression, not includingdeath.

Time frame
Outcome will be measured after 1, 3, 5 and 16 years.
3

Absorbed dose to organs at risk.

Will be collected from Dose Volume Histograms.

Time frame
Outcome will be measured at baseline.
4

Patterns of failure.

Are failures located within or outside of the radiation field?

Time frame
Outcome will be measured after 1, 3, 5 and 16 years.

Other outcomes

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