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Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Sponsor: Ruijin Hospital
Summary
This is a multicenter, open-label, randomized, phase 3 superiority trial. The purpose is to find out whether a risk-adapted segmental esophagus-sparing radiotherapy plan is better than a standard radiotherapy plan at reducing moderate or worse acute radiation esophagitis in adults with locally advanced non-small cell lung cancer (NSCLC) who are receiving definitive concurrent or sequential chemoradiotherapy, with or without immunotherapy. Acute radiation esophagitis is inflammation of the esophagus caused by radiation; it can cause swallowing pain or difficulty and may interrupt treatment. The study will also check whether the esophagus-sparing plan affects tumor control, survival, other side effects, and quality of life. About 140 participants will be randomly assigned 1:1 to the esophagus-sparing plan or the standard plan. Randomization will be stratified by study center, concurrent versus sequential chemoradiotherapy, ECOG performance status, and PD-L1 expression. In the esophagus-sparing group, the radiotherapy plan sets graded average dose limits to parts of the esophagus near the tumor target, based on how much the target overlaps the esophagus. The standard group receives routine intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) without active esophagus avoidance. Both groups receive the same radiotherapy dose (60-66 Gy in 30-33 fractions) and the same chemotherapy/immunotherapy chosen by their doctors. The study is open-label, so participants and doctors will know which radiotherapy plan is used; the main statistical analysis will be blinded to group assignment. The main measure is the proportion of participants with Grade 2 or higher acute radiation esophagitis within 3 months after starting radiotherapy, graded by CTCAE v5.0. Participants will be followed for up to 24 months after randomization. This study does not test a new drug or device.
Official title: Risk-Adapted Segmental Esophagus-Sparing Radiotherapy in the Definitive Treatment of Non-Small Cell Lung Cancer: A Multicenter, Open-Label, Randomized, Phase III Superiority Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-10-30
Completion Date
2031-12-30
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT
External-beam radiotherapy using IMRT or VMAT, 60-66 Gy in 30-33 fractions, once daily, 5 days/week, with concurrent or sequential chemotherapy with or without immunotherapy selected by the treating oncologist (same as control arm). This is a radiotherapy planning intervention, not a new drug or device. Esophagus-related structures are defined from the PTV: Eso-inv (PTV-esophagus overlap), Eso-con (contralateral esophagus at the same level), IEE (Eso-inv + Eso-con extended 2 cm craniocaudally), and Eso-spare (esophagus within IEE but outside Eso-inv). The Eso-spare mean dose is constrained by PTV/IEE overlap: \<1/3, ≤1/2 prescription dose; 1/3-2/3, ≤1/2 prescription dose; ≥2/3, ≤2/3 prescription dose. For the \<1/3 group, backup constraints are Eso-spare V55 \<1 cc and V60 \<0.5 cc with PTV V95 ≥95%. Priority: GTV/CTV/PTV coverage, routine OAR limits, then Eso-spare constraints.
Standard IMRT/VMAT Without Active Esophageal Avoidance
External-beam radiotherapy using standard IMRT or VMAT, 60-66 Gy in 30-33 fractions, once daily, 5 days/week, with concurrent or sequential chemotherapy with or without immunotherapy selected by the treating oncologist (same as study arm). This is a radiotherapy planning intervention, not a new drug or device. No active esophageal avoidance is performed: Eso-spare is not delineated and no esophageal mean dose limit is applied. Only routine organ-at-risk constraints are required: spinal cord Dmax \<45 Gy; heart Dmean \<20 Gy; lungs V20 \<30%, V5 \<60%, and Dmean \<15 Gy; and routine whole-esophagus limits (e.g., V60 \<20%, V40 \<40%). Target coverage follows standard clinical requirements. This arm distinguishes from the study arm by the absence of risk-adapted segmental esophageal dose constraints.