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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGSkane University Hospital
Lund, Sweden
RECRUITINGOrebro University Hospital
Örebro, Sweden
RECRUITINGKarolinska University Hospital
Solna, Sweden
RECRUITINGUmea University Hospital
Umeå, Sweden
RECRUITINGUppsala University Hospital
Uppsala, Sweden
RECRUITINGProgression 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.
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.
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.
Absorbed dose to organs at risk.
Will be collected from Dose Volume Histograms.
Time frame: Outcome will be measured at baseline.
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.
Acute adverse events.
The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy.
Time frame: Outcome will be measured within 3 months.
Long-term adverse events.
This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
EORTC quality of life questionnaire (QLQ)-C30.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
EORTC quality of life questionnaire (QLQ)-Hodgkin lymphoma (HL)27.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
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