Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
About this study
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.
- Condition
- Hodgkin Lymphoma
- Tested
- Proton therapy.
- Sponsor
- Uppsala University Hospital
Who can join
- Age
- 18 to 60 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 15
- Minimum age: 18 years
- Maximum age: 60 years
- Study condition: Hodgkin Lymphoma
- 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 6
- 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
6 sites, 6 recruiting
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
Contact
-
Daniel Molin, MD, PhD
+46186110000 daniel.molin@igp.uu.se
-
Christina Goldkuhl, MD
+46313421000 christina.goldkuhl@vgregion.se
Potential match only. Final eligibility is determined by the study team.