Proton therapy for Hodgkin Lymphoma patients
Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
This study is testing if proton therapy is a safer and effective treatment for early-stage Hodgkin Lymphoma patients who have already had chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT06883604 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with classic Hodgkin Lymphoma at Ann Arbor stages 1A, 1B, or 2A, who have received induction chemotherapy.
Not a fit: Patients with advanced-stage Hodgkin Lymphoma or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce late toxicity in Hodgkin Lymphoma patients while preserving treatment effectiveness.
How similar studies have performed: Previous studies have indicated the potential benefits of proton therapy in reducing side effects compared to conventional radiotherapy, suggesting a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gothenburg and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.