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

NCT06883604 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Proton therapy.

Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • University Hospital of Umeå

    collaborator UNKNOWN

  • Region Örebro County

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • University Hospital, Linkoeping

    collaborator OTHER

  • Skandion Clinic

    collaborator UNKNOWN

  • Swedish Cancer Society

    collaborator OTHER

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Daniel Molin, MD, PhD · Uppsala University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-06-30
Completion
2041-06-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883604 on ClinicalTrials.gov