A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC)

Sichuan Cancer Hospital and Research Institute4 sites in 1 country46 target enrollmentJanuary 1, 2021

ConditionsNon-small Cell Lung Cancer Stage III Non-small Cell Lung Cancer Stage II

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer Stage III
Sponsor: Sichuan Cancer Hospital and Research Institute
Enrollment: 46
Locations: 4
Primary Endpoint: FPS
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.

Detailed Description

The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer. The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.

Registry

clinicaltrials.gov

Start Date

January 1, 2021

End Date

December 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan Cancer Hospital and Research Institute

Responsible Party

Principal Investigator

LI TAO

Researcher

Sichuan Cancer Hospital and Research Institute

Eligibility Criteria

Inclusion Criteria

•The patient or the legal representative of the patient can sign a written informed consent, and can understand and agree to follow the research requirements;
•The age at the time of signing the informed consent form is between 18 and 75 years old;
•It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
•Stage II-Ⅲ (AJCC 8th edition \[Rice et al., 2017\]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
•Measurable lesions that meet the definition of RECISTv1.1;
•ECOG physical status ≤ 2;
•Survival expectancy ≥ 3 months;
•Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
•Liver function: ALT, AST\<1.5 times the upper limit of normal (ULN), total bilirubin\<1.5×ULN;
•Renal function: serum creatinine \<1.5×ULN;

Exclusion Criteria

•There is evidence of distant metastasis (M1, AJCC 8th edition \[Rice et al., 2017\]);
•There is pleural effusion, pericardial effusion or ascites that is not clinically controlled and requires repeated drainage or medical intervention (within 2 weeks before randomization);
•Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
•Have received radiotherapy and surgical treatment;
•There were other active malignant tumors ≤ 2 years before enrollment, except for the specific cancers under study in this study and locally recurring cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial Bladder cancer, carcinoma in situ of the cervix or breast);
•A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
•Has suffered from other malignant tumors;
•Subjects who have received other drug trials within the past month;
•Pregnant or lactating women and women who refuse contraception during the treatment observation period;
•People with a history of severe allergies or idiosyncratic physique;

Outcomes

Primary Outcomes

FPS

Time Frame: up to 3 years

progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set.