NCT06883604Recruiting
Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 8 Mar 2025
- Start date
- 1 Sept 2019
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Uppsala University Hospital
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT06883604
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 1 Sept 2019 to the primary completion date, 30 Jun 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant systemic disorder endangering treatment delivery.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Örebro University Hospital Coordinator of this site? Confirm its status | Örebro | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Umeå University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.