Dose-painting Radiation for LA-NSCLC

NCT ID: NCT05031533

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assigned Interventions

Radiation therapy: Dose-painting radiation

Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status

(1) Chemotherapy

1. Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles.

2. Non-squamous cell carcinoma (adenocarcinoma, large cell carcinoma): Pemetrexed 500mg/m2 d1 + Cisplatin 75 mg/m2 d1-3, a total of 2-4 cycles.

(2) Targeted therapy: According to the patient's genetic testing status, molecular targeted therapy such as EGFR-TKI and ALK inhibitors can be selected; (3) Immunotherapy: According to the patient's genetic testing status, immunotherapy such as PD1/PD-L1 inhibitors can be selected;

Group Type: EXPERIMENTAL

Dose-Painting Radiation

Intervention Type: RADIATION

Radiation therapy:

1. 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.

2. 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

Interventions

Dose-Painting Radiation

Radiation therapy:

1. 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.

2. 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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

LI TAO

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, China

Site Status: RECRUITING

Yunnan Cancer Hospital

Kunming, , China

Site Status: RECRUITING

Chongqing university three Gorges hospital

Wanzhou, , China

Site Status: RECRUITING

General Hospital of Ningxia Medical University

Yingchuan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiahua Lyu, Doctor

Role: CONTACT

winlttljh@163.com

+86-17713539529

Tao Li

Role: CONTACT

Facility Contacts

Tao Li, Doctor

Role: primary

litaoxmf@163.com

86-18908178818

Yaoxiong Xia

Role: primary

Shichuan Chang

Role: primary

Ren Zhao

Role: primary

Other Identifiers

SCCHEC202108

Identifier Type: -

Identifier Source: org_study_id