Dose-painting Radiation for LA-NSCLC

NCT05031533 | Unknown DMC

• 1 other identifier: SCCHEC202108
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ORR

  up to 3 years

• OS

  up to 3 years

• HRQoL

  up to 3 years

Other Outcomes (2)

• Prognostic Biomarkers

  up to 8 weeks

• Prognostic Biomarkers

  up to 8 weeks

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

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;

Radiation: Dose-Painting Radiation

Interventions

Dose-Painting Radiation 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

Assigned Interventions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Pulmonary function: FEV1\>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value\>80% mild to moderate lung function impairment.
• The patient has good compliance with the treatment and follow-up.

You may not qualify if:

• 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;
• Those with a history of severe lung or heart disease;
• Refusal or inability to sign the informed consent to participate in the trial;
• Drug or alcohol addicts;
• Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (4)

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

RECRUITING

Yunnan Cancer Hospital

Kunming, China

RECRUITING

Chongqing university three Gorges hospital

Wanzhou, China

RECRUITING

General Hospital of Ningxia Medical University

Yingchuan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jiahua Lyu, Doctor

CONTACT

+86-17713539529; winlttljh@163.com

Tao Li

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 2, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

CN (4)