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

Not Applicable

Recruiting

• Conditions: Hodgkin Lymphoma

• Registration Number: NCT06883604
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-15
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-06
• Study Completion: 2041-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Outcome will be measured after 1, 3, 5 and 16 years.	Time from study entry until disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Outcome will be measured after 1, 3, 5 and 16 years.	Time from diagnostic biopsy until death from any cause.
Time to progression (TTP)	Outcome will be measured after 1, 3, 5 and 16 years.	Time from diagnostic biopsy until objective tumor progression, not includingdeath.
Absorbed dose to organs at risk.	Outcome will be measured at baseline.	Will be collected from Dose Volume Histograms.
Patterns of failure.	Outcome will be measured after 1, 3, 5 and 16 years.	Are failures located within or outside of the radiation field?
Acute adverse events.	Outcome will be measured within 3 months.	The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy.
Long-term adverse events.	Outcome will be measured after 1, 3, 5 and 16 years.	This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later.
Quality of life.	Outcome will be measured after 1, 3, 5 and 16 years.	EORTC quality of life questionnaire (QLQ)-Hodgkin lymphoma (HL)27.

Trial Locations

Locations (6)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Umea University Hospital; 🇸🇪 Umea, Sweden

Skane University Hospital; 🇸🇪 Lund, Sweden

Orebro University Hospital; 🇸🇪 Orebro, Sweden

Karolinska University Hospital; 🇸🇪 Solna, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden