NCT06883604 Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
| NCT ID | NCT06883604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University Hospital |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2019-09-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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. * Not able to comply with treatment and study procedures. * 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.
Contact & Investigator
Daniel Molin, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT06883604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883604 currently recruiting?
Yes, NCT06883604 is actively recruiting participants. Contact the research team at daniel.molin@igp.uu.se for enrollment information.
Where is the NCT06883604 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Lund, Sweden, Örebro, Sweden, Solna, Sweden and 2 additional locations.
Who is sponsoring the NCT06883604 clinical trial?
NCT06883604 is sponsored by Uppsala University Hospital. The principal investigator is Daniel Molin, MD, PhD at Uppsala University Hospital. The trial plans to enroll 75 participants.