Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
Aim To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy.
Hypothesis The trial hypothesis is that proton therapy is less toxic than photon therapy in fragile patients and that this difference will mitigate to a difference in overall survival.
Design Multicentre, randomized phase II study 1:1 Sample size 182 patients (91 in each arm) Treatment Radiotherapy (inhomogeneous dose distribution) 50 Gy/ 24 fraction Endpoint Primary: Overall survival at 12 months Secondary: progression free survival, time to loco-regional and distant failure, pattern of failure, acute and late toxicity, quality of life, patient compliance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological or cytological confirmed LA_NSCLC
Not candidate for definitive chemo-radiotherapy
Performance status 0-2
Signed informed consent
Disqualifiers
Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.
Uncontrolled other malignant disease.
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Photon
Radiation50-66Gy/ 24 fractions, inhomogeneous dose distribution photon therapy
Proton
Radiation50-66Gy/ 24 fractions, inhomogeneous dose distribution proton therapy
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: Photon therapyActive comparator 1 intervention
Group B: Proton therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
OS at 12 months after randomization
Overall survival 12 months after randomization
Time frame
12 month after patient randomizationSecondary outcomes
1
Acute toxicity
Number of patients with acute toxicity, defined as any radiotherapy related toxicity occurring up to 9 months after randomization
Time frame
9 months after patient randomization2
Late toxicity
Number of patients with late toxicity, defined as any radiotherapy related toxicity occurring later than 9 months after randomization.
Time frame
Up to 5 years after patient randomization3
Progression free survival
Any progression or recurrence (locoregional or distant) as well as death from any cause, whatever occurs first, will be considered as events
Time frame
up to 5 years after patient randomization4
Pattern of faillure
First site of failure will be divided in primary tumour, bulky lymph nodes, non-bulky lymph node targets, regional lymph nodes not included in target delineation/ irradiated, and distant failures.
Time frame
up to 5 years after patient randomizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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