Proton therapy for Hodgkin Lymphoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation evaluates the safety and efficacy of proton therapy in patients with early-stage Hodgkin Lymphoma who have undergone induction chemotherapy. The study aims to minimize late side effects associated with conventional radiotherapy while maintaining high cure rates. It is a multicenter phase II study comparing proton beam therapy to historical data from patients treated with photon therapy. Participants will be monitored for treatment outcomes and side effects over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Skane University Hospital
  Lund, Sweden Recruiting
• Orebro University Hospital
  Örebro, Sweden Recruiting
• Karolinska University Hospital
  Solna, Sweden Recruiting
• Umea University Hospital
  Umeå, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Daniel Molin, MD, PhD — Uppsala University Hospital
• Study coordinator: Daniel Molin, MD, PhD
• Email: daniel.molin@igp.uu.se
• Phone: +46186110000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.