Dose-painting Radiation for LA-NSCLC

Non-small Cell Lung Cancer Stage III Clinical Trial

— DPRLC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031533
• Other study ID #: SCCHEC202108
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: August 2021
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: Jiahua Lyu, Doctor
• Phone: +86-17713539529
• Email: winlttljh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-? (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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage II
• Non-small Cell Lung Cancer Stage III

Intervention

Radiation:
• Dose-Painting Radiation
Radiation therapy: Delineation of target area: The primary tumor is delineated into different target areas according to the anatomical position of the tumor, including the central area tumor GTV-Tcentral and GTV-Tperipheral. Exposure dose: 1) GTV-Tcentral: 2.0~2.5Gy/f, bid, 10-13d, physical dose 40-65Gy 2) GTV-Tperipheral: 3.0~4.0Gy/f, bid, 10-13d, physical dose 60-104Gy 3) GTV-N (mediastinal lymph node): 2.0Gy/f, bid, 10-13d, physical dose 40-52Gy

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital & Institute	Chengdu	Sichuan
China	Yunnan Cancer Hospital	Kunming
China	Chongqing university three Gorges hospital	Wanzhou
China	General Hospital of Ningxia Medical University	Yingchuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prognostic Biomarkers	The expression of lymphocyte subsets in peripheral blood, including CD3+ T cells, CD4+ T cells, CD8+ T cells, CD8+CD28+ T cells, CD8+CD28- T cells, Treg cells, NK cells, NKT cells, ?d T cells;	up to 8 weeks
Other	Prognostic Biomarkers	The changing trend of various cytokines in radiotherapy, including IL-6, IL-1b, IL-9, TNF-a, TGF-ß, IL-10, IL-21, etc.	up to 8 weeks
Primary	FPS	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.	up to 3 years
Secondary	ORR	Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission	up to 3 years
Secondary	OS	OS(Overall survival) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).	up to 3 years
Secondary	HRQoL	HRQoL uses EORTCQLQ-C30 to assess the overall health of patients. The post-baseline score of the treatment group was studied, and the score changes from the baseline were summarized descriptively.	up to 3 years