Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

Launched by UPPSALA UNIVERSITY HOSPITAL · Mar 15, 2025

Keywords

ClinConnect Summary

The PRO-Hodgkin trial is studying a new type of treatment called proton therapy for patients with early stage Hodgkin Lymphoma. This trial aims to find out if using proton therapy can be just as effective as traditional radiotherapy while causing fewer long-term side effects, like heart or lung problems and the risk of developing a second cancer. Participants in this trial will receive proton therapy after undergoing chemotherapy, and the study will compare their outcomes to those of past patients who received standard radiotherapy.

To be eligible for this trial, patients need to be between 18 and 60 years old and have a confirmed diagnosis of classic Hodgkin Lymphoma at an early stage (stages 1A, 1B, or 2A). They should have received a specific amount of chemotherapy before entering the study. Patients will need to provide informed consent and follow certain guidelines, such as using contraceptives if they are of childbearing age. Throughout the trial, participants can expect regular check-ups and monitoring to ensure their safety and the treatment's effectiveness. This study is currently recruiting participants who meet these criteria.

Gender

ALL

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.