Clinical trial NCT06883604: Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Official title: Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hodgkin Lymphoma
Keywords: Proton therapy
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: University Hospital of Umeå
name: Region Örebro County
name: Karolinska University Hospital
name: Skane University Hospital
name: University Hospital, Linkoeping
name: Skandion Clinic
name: Swedish Cancer Society
First posted: 2025-03-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proton therapy, non-inferiority compared to historical cohort.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
measure: Time to progression (TTP)
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
measure: Absorbed dose to organs at risk.
timeFrame: Outcome will be measured at baseline.
measure: Patterns of failure.
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
measure: Acute adverse events.
timeFrame: Outcome will be measured within 3 months.
measure: Long-term adverse events.
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
measure: Quality of life.
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
measure: Quality of life.
timeFrame: Outcome will be measured after 1, 3, 5 and 16 years.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Umea
country: Sweden
facility: Umea University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Daniel Molin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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