Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI

Trial Title: Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI

NCT ID: NCT06545747

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents

Conditions: Keywords:
hypo-fractionated radiotherapy
consolidative immunotherapy
MRI-guided

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: DCE-MRI based split-course hypo-RT
Description: Tumor delineation will be based on DCE-MRI and CT. MRI help define the tumor boundary. Different radiation doses will be delivered based on the Ktrans value of the tumor area on DCE-MRI.
Arm group label: MRI-based hypo-RT

Intervention type: Radiation
Intervention name: CT based split-course hypo-RT
Description: Tumor delineation will be based on CT. The total dose for both the first and boost courses of hypo-RT to the tumor area will be constant.
Arm group label: CT-based hypo-RT

Intervention type: Drug
Intervention name: Concurrent chemotherapy
Description: Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2，d1.
Arm group label: CT-based hypo-RT
Arm group label: MRI-based hypo-RT

Intervention type: Drug
Intervention name: Consolidative immunotherapy
Description: Consolidative PD-1/PD-L1 inhibitors
Arm group label: CT-based hypo-RT
Arm group label: MRI-based hypo-RT

Summary: This study is a randomized phase III trial that aiming to investigate the role of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) guided hypofractionated radiotherapy (hypo-RT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are planned to receive hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. Patients will be randomized in a 1:1 ratio into two groups: 1. The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI. 2. The control group will undergo hypo-RT based on enhanced CT. The treatment-related toxicity, local control and long-term survival will be evaluated compared between MRI-guided and CT-guided hypo-RT.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Male or female aged between 18 and 75 years old. - Patients must have histological or cytological confirmation of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC). - No prior radiation therapy or surgery. - Expected life expectancy of at least 12 weeks. - World Health Organization (WHO) performance status score of 0 or 1. - Able to undergo magnetic resonance imaging (MRI) examination. - Organ and bone marrow function meeting the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 ml; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0 g/dL; Serum creatinine clearance rate calculated by the Cockcroft-Gault formula ≥ 50 mL/min (Cockcroft and Gault 1976); Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN. Exclusion Criteria: - Contraindications to MRI examination. - Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study. - Histological type of mixed small cell and non-small cell lung cancer. - Major surgery performed within 4 weeks prior to entering the study (excluding vascular access). - History or occurrence of autoimmune disease within the past 2 years. - Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). - History of primary immunodeficiency. - History of organ transplantation requiring immunosuppressive therapy. - Average QT interval (QTc) ≥ 470 ms calculated from 3 ECG cycles using Bazett's correction. - Uncontrolled comorbidities, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active bleeding disorder, human immunodeficiency virus (HIV), or psychiatric/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent. - Active tuberculosis. - Receipt of a live attenuated vaccine within 30 days prior to the start of the study. - History of another primary malignancy within 5 years, excluding adequately treated basal or squamous cell skin cancer or in situ cervical cancer. - Pregnant or breastfeeding women; or males and females of reproductive potential not using effective contraception.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Bo Qiu, MD

Phone: 02087343031
Email: qiubo@sysucc.org.cn

Start date: January 1, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06545747