Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Concord Cancer Center
About this trial
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
.Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after multidisciplinary team (MDT) discussion.
The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
Age: 18 years and above.
Karnofsky(KPS) score ≥60.
Disqualifiers
Patients with other malignant tumors.
Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
Those whose laboratory test values do not meet relevant standards before enrollment.
Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Body Proton Therapy
RadiationThey were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Stereotactic Body Proton TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free Survival
Progression Free Survival(PFS) is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method
Time frame
Up to 3 yearsSecondary outcomes
1
Overall Survival
Overall Survival (OS) is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method.
Time frame
UP to 3 years2
Local Control Rate
Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years.
Time frame
Up to 3 years3
Quality of life scores
European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC QLQ-C30) (V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Time frame
Up to 3 years4
Quality of life scores
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 29(EORTC QLQ-LC29) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov