RecruitingNot ApplicableNCT06883604

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

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


Sponsor

Uppsala University Hospital

Enrollment

75 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating proton beam radiotherapy — a highly targeted form of radiation that may cause fewer side effects to surrounding tissues — compared to standard radiation in patients with early-stage Hodgkin lymphoma after chemotherapy. **You may be eligible if...** - You are between 18 and 60 years old - You have been diagnosed with classic Hodgkin lymphoma, stage 1A, 1B, or 2A - Your cancer is located above the diaphragm (chest/neck area) - You have completed the required cycles of ABVD chemotherapy (2 or 4 cycles depending on risk factors) and your cancer has responded - Radiation is planned to start within 6 weeks after finishing chemotherapy **You may NOT be eligible if...** - You are pregnant - You have a serious co-existing illness that would make treatment unsafe - Your cancer progressed or did not respond during chemotherapy - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton therapy.

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


Locations(6)

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Lund, Sweden

Orebro University Hospital

Örebro, Sweden

Karolinska University Hospital

Solna, Sweden

Umea University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

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NCT06883604


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