Hodgkin Lymphoma
Conditions
Keywords
Proton therapy
Brief 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.
Interventions
RADIATIONProton therapy.
Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
Sponsors
Sahlgrenska University Hospital
University Hospital of Umeå
Region Örebro County
Karolinska University Hospital
Skane University Hospital
University Hospital, Linkoeping
Skandion Clinic
Swedish Cancer Society
Uppsala University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Proton therapy, non-inferiority compared to historical cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Outcome will be measured after 1, 3, 5 and 16 years. | Time from study entry until disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression (TTP) | Outcome will be measured after 1, 3, 5 and 16 years. | Time from diagnostic biopsy until objective tumor progression, not includingdeath. |
| Absorbed dose to organs at risk. | Outcome will be measured at baseline. | Will be collected from Dose Volume Histograms. |
| Patterns of failure. | Outcome will be measured after 1, 3, 5 and 16 years. | Are failures located within or outside of the radiation field? |
| Overall survival (OS) | Outcome will be measured after 1, 3, 5 and 16 years. | Time from diagnostic biopsy until death from any cause. |
| Long-term adverse events. | Outcome will be measured after 1, 3, 5 and 16 years. | This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later. |
| Quality of life. | Outcome will be measured after 1, 3, 5 and 16 years. | EORTC quality of life questionnaire (QLQ)-C30. |
| Acute adverse events. | Outcome will be measured within 3 months. | The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy. |
Countries
Sweden
Contacts
Primary ContactDaniel Molin, MD, PhD
Backup ContactChristina Goldkuhl, MD
Outcome results
None listed