Actively Recruiting
Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Led by Uppsala University Hospital · Updated on 2025-03-19
75
Participants Needed
6
Research Sites
1134 weeks
Total Duration
On this page
Sponsors
U
Uppsala University Hospital
Lead Sponsor
S
Sahlgrenska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of classic Hodgkin Lymphoma
- Ann Arbour stage 1A, 1B or 2A
- Patients with or without risk factors such as bulky disease, ESR >50, or more than two involved sites
- Supra diaphragmal disease
- Age between 18 and 60 years
- ECOG performance status 0 to 2
- Initial staging with PET/CT
- Induction chemotherapy with 2 cycles of ABVD for patients without risk factors, 4 cycles for those with risk factors
- For patients with risk factors, CT after 2 ABVD cycles confirming complete or partial remission; for others, clinical response sufficient but CT recommended before radiotherapy
- Radiotherapy to start no later than 6 weeks after chemotherapy ends
- Written informed consent obtained
- Women of reproductive age must agree to use contraceptives during treatment period
You will not qualify if you...
- Pregnancy
- Serious systemic disorder that endangers treatment delivery
- Tumor motion over 5mm on 4DCT unless using deep inspiration breath hold; not applicable if target is outside mediastinum or photon treatment planned
- Stable or progressive disease during induction chemotherapy
- Inability to comply with treatment and study procedures
- Presence of additional active malignancy except indolent lymphoma in bone marrow, basal cell carcinoma of skin, squamous cell carcinoma of skin, or in situ cervical cancer
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Trial Site Locations
Total: 6 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden, S-41345
Actively Recruiting
2
Skane University Hospital
Lund, Sweden, S-22242
Actively Recruiting
3
Orebro University Hospital
Örebro, Sweden, S-70185
Actively Recruiting
4
Karolinska University Hospital
Solna, Sweden, S-17176
Actively Recruiting
5
Umea University Hospital
Umeå, Sweden, S-90737
Actively Recruiting
6
Uppsala University Hospital
Uppsala, Sweden, S-75185
Actively Recruiting
Research Team
D
Daniel Molin, MD, PhD
CONTACT
C
Christina Goldkuhl, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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