Proton Therapy for Mediastinal Lymphoma (PROMLY)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior radiotherapy to the thorax
Other current malignancy
Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.
Trial design
Design model
Single group
Treatments tested in this trial
Proton therapy
RadiationIf selected, patients will recieve protontherapy instead of photon therapy
Treatment groups
139 Participants
are divided into 1 treatment groupGroup A: ProtonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlation between ΔNTCP_expected and ΔNTCP_delivered.
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.
Time frame
From enrollment to end of radiotherapy, average 5 weeks.Secondary outcomes
1
Incidence of acute, late toxicity and other events
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
Time frame
From enrollment to 20 years after end of radiationOther outcomes
1
Radiation dosimetry
Data from the study will be compared between 1\) Patients treated with protons vs patients treated with photons. 2) Data from the study compared to Historical data. 3) NTCP estimated risk vs. actual events (protons and photons).
Time frame
From enrollment to 20 years after end of radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
Collaborator
Aalborg University Hospital
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov