Clinical trial NCT05031533: Dose-painting Radiation for LA-NSCLC
Official title: A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer Stage III
Non-small Cell Lung Cancer Stage II
Keywords: radiotherapy
dose-painting radiation
non-small cell lung cancer
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. The age at the time of signing the informed consent form is between 18 and 75 years old;
3. It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
4. Stage II-Ⅲ (AJCC 8th edition \[Rice et al., 2017\]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
5. Measurable lesions that meet the definition of RECISTv1.1;
6. ECOG physical status ≤ 2;
7. Survival expectancy ≥ 3 months;
8. Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
9. Liver function: ALT, AST\<1.5 times the upper limit of normal (ULN), total bilirubin\<1.5×ULN;
10. Renal function: serum creatinine \<1.5×ULN;
11. Pulmonary function: FEV1\>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value\>80% mild to moderate lung function impairment.
12. The patient has good compliance with the treatment and follow-up.

Exclusion Criteria:

1. There is evidence of distant metastasis (M1, AJCC 8th edition \[Rice et al., 2017\]);
2. 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);
3. Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
4. Have received radiotherapy and surgical treatment;
5. 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);
6. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
7. Has suffered from other malignant tumors;
8. Subjects who have received other drug trials within the past month;
9. Pregnant or lactating women and women who refuse contraception during the treatment observation period;
10. People with a history of severe allergies or idiosyncratic physique;
11. Those with a history of severe lung or heart disease;
12. Refusal or inability to sign the informed consent to participate in the trial;
13. Drug or alcohol addicts;
14. Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.

Primary outcomes:
measure: FPS
timeFrame: up to 3 years
Secondary outcomes:
measure: ORR
timeFrame: up to 3 years
measure: OS
timeFrame: up to 3 years
measure: HRQoL
timeFrame: up to 3 years
Other outcomes:
measure: Prognostic Biomarkers
timeFrame: up to 8 weeks
measure: Prognostic Biomarkers
timeFrame: up to 8 weeks
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
state: Sichuan
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Wanzhou
country: China
facility: Chongqing university three Gorges hospital
city: Yingchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
References: