Tests proton radiotherapy in Hodgkin lymphoma patients after chemotherapy
Tests proton radiation after chemotherapy in adults up to age 60 with early Hodgkin lymphoma.
Plain-language title generated from the registry record
Registry title: Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Key facts
- Where
- Gothenburg, Lund, Örebro, Solna, Umeå, and Uppsala, SwedenSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06883604, who can take part
Where in Sweden
- Sahlgrenska University HospitalGothenburg, SwedenTaking people
- Skåne University HospitalLund, SwedenTaking people
- Örebro University HospitalÖrebro, SwedenTaking people
- Karolinska University HospitalSolna, SwedenTaking people
- Umeå University HospitalUmeå, SwedenTaking people
- Uppsala University HospitalUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uppsala University Hospital
- Trial code
- NCT06883604
- Record updated
- 19 March 2025
- Original description
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.Read full original descriptionShow less
Clinical Investigation of PBS 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.
Inclusion: 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; Age 18-60 years; Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2; Initial staging positron emission tomography/computed tomography (PET/CT); Induction chemotherapy including 2 cycles of ABVD for patients without risk factors and 4 cycles of ABVD for patients with risk factors; For patients with risk factors a CT after 2 ABVD confirming complete remission (CR) or partial remission (PR). For patients without risk factors clinical response is sufficient at inclusion, but a CT scan is recommended before start of radiotherapy; Radiotherapy (RT) start not later than 6 weeks after end of chemotherapy; Written informed consent obtained prior to any study specific procedures; Women of reproductive age must agree to use contraceptives during the study treatment period.
Exclusion: Serious concomitant systemic disorder endangering treatment delivery; Clinical or radiographic stable disease (SD)/ progressive disease (PD) during induction chemotherapy; No additional active malignancy except indolent lymphoma in the bone marrow, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer; Pregnancy; 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; Not able to comply with treatment and study procedures.