Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Proton and Heavy Ion Center
About this trial
To investigate the efficacy of carbon ion therapy for stage Ia-IIa primary peripheral non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was local control rate, overall survival (OS) and toxicities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 18 and 80.
ECOG general status score of 0-2 .
Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition).
The location of the tumor belongs to the peripheral type defined in this study (2cm and beyond (≥2cm) from the esophagus, main bronchial tree, spinal cord, heart, great blood vessels, brachial plexus and stomach, and 1cm and beyond (≥1cm) from the chest wall).
Disqualifiers
Multiple primary tumors.
Patient fails to comply with the treatment protocol.
Complicated with other malignant tumors that have not been controlled.
Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
Trial design
Design model
Single group
Treatments tested in this trial
Carbon ion beam radiotherapy
RadiationPatients receive carbon ion radiotherapy of 12GyE per fraction, totally 4 fractions. Patients with tumors ≥4cm should receive at least 4 cycles of platinum-based doublet chemotherapy.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Study armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
disease progression-free survival rate
disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.
Time frame
From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsSecondary outcomes
1
local control rate
local control rate was defined was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up
Time frame
From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months2
overall survival rate
overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up
Time frame
From date of radiotherapy started until the date of death from any cause, assessed up to 100 months3
Incidence of Treatment-induced Adverse Events [Safety and Tolerability]
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.
Time frame
From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 monthsSponsors and contacts
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Source ClinicalTrials.gov