Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Disease Lymphoma, Mediastinal Lymphoma
Conditions
Keywords
proton therapy, mediastinal lymphoma, NTCP, normal tissue complication probability, Hodgkin Lymphoma, Lymphoma
Brief summary
The study aims to investigate whether proton therapy is feasible in a national setting and whether proton therapy can reduce the risk of late toxicity (secondary cancers and heart toxicity) compared to foton therapy.
Detailed description
Patients are referred for proton therapy based on a reduction of risk of late toxicity which is established on consensus guidelines and multidisciplinary discussions in a study panel/consensus conference. However, this reduction is calculated based on the referring center's treatment planning scan and patient setup. The aim of this national study is to investigate whether the calculated reduction of risk of toxicity with proton therapy at the referring centers differs from the actual delivered plan at DCPT (ΔNTCP in delivered proton therapy plan versus reference photon plan from referring center). The study also aims to investigate effect and side effects of proton and photon radiotherapy, including a systematically prospective registration of acute and late side effects and to evaluate the use of a model-based approach to select patients for proton therapy.
Interventions
RADIATIONProton therapy
If selected, patients will recieve protontherapy instead of photon therapy
Sponsors
Rigshospitalet, Denmark
Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
Aalborg University Hospital
Odense University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years or older * Histologically proven Hodgkin or non-Hodgkin lymphoma * Disease constrained within the mediastinum +/- neck and/or axilla involvement. * Candidates for curative intended treatment * Signed written informed consent.
Exclusion criteria
* Prior radiotherapy to the thorax * Other current malignancy * Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between ΔNTCP_expected and ΔNTCP_delivered. | From enrollment to end of radiotherapy, average 5 weeks. | The correlation between ΔNTCP\_expected and ΔNTCP\_delivered, is an investigation to see whether the ΔNTCP (ΔNTCP\_expected) calculated from the planning CT from the refering center, correlates with the ΔNTCP from the actual delivered plan (ΔNTCP\_delivered) at the Danish Centre for Particle Therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute, late toxicity and other events | From enrollment to 20 years after end of radiation | A) Acute toxicity 1. Radiation dermatitis 2. Cough 3. Fatigue 4. Dysphagia Add a 2nd Outcome Measure B) Incidence of: 1. secondary cancers (breast and lung) 2. other secondary cancers within the radiation field. 3. Myocardial infarction 4. Other cardiac events Add a 3rd Outcome Measure C) Overall survival Add a 4th Outcome Measure D) Recurrence free survival |
Countries
Denmark
Contacts
CONTACTMogens Bernsdorf, Md. Phd
Outcome results
None listed