A Phase 3 interventional study of Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT and Standard IMRT/VMAT Without Active Esophageal Avoidance in Non-Small Cell Lung Cancer, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Ruijin Hospital · Phase 3, Interventional, and Treatment
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.
6,666 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,682 are open to participants now.
This study's planned enrollment of 140 is above the median of 62 across 5,345 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Ruijin Hospital is the lead sponsor of 674 studies on the registry; 382 are open to participants now.
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Exclusion Criteria:
Participants receive risk-adapted segmental esophagus-sparing Intensity-Modulated Radiation Therapy (IMRT)/Volumetric Modulated Arc Therapy (VMAT), with concurrent or sequential chemotherapy with or without immunotherapy. Esophagus-related structures \[Esophagus-Involved(Eso-inv), Esophagus-Contralateral(Eso-con), Injury-Effective Esophagus(IEE), and Esophagus-Sparing(Eso-spare)\] are defined based on the Planning Target Volume (PTV). The Eso-spare mean dose is constrained by the PTV/IEE overlap ratio: \<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 absolute volume constraints (Eso-spare V55 \<1 cc and V60 \<0.5 cc) are allowed while maintaining PTV V95 ≥95%. Target coverage and routine organ-at-risk limits are prioritized. Chemotherapy/immunotherapy is selected by the treating oncologist and is the same as in the control arm.
Radiation: Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT
Participants receive standard IMRT/VMAT, with concurrent or sequential chemotherapy with or without immunotherapy, without active esophageal avoidance. 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 (V60 \<20%, V40 \<40%). Chemotherapy/immunotherapy is selected by the treating oncologist and is the same as in the study arm.
Radiation: Standard IMRT/VMAT Without Active Esophageal Avoidance
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.
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.
Also known as: Standard Radiotherapy Plan
Incidence of Grade 2 or Higher Acute Radiation Esophagitis (CTCAE v5.0)
Proportion of participants who develop Grade 2 or higher acute radiation esophagitis, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, from the start of radiotherapy until 3 months after the end of radiotherapy. The primary analysis will use the intention-to-treat population. The primary endpoint will be assessed by investigators; the statistical analysis will be performed by an independent statistician blinded to treatment allocation.
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy (approximately 4.5-5 months after radiotherapy initiation)
Incidence of Any-Grade Acute Radiation Esophagitis
Proportion of participants who develop any-grade acute radiation esophagitis, assessed by both CTCAE v5.0 and RTOG criteria. Events occurring from the start of radiotherapy until 3 months after completion of radiotherapy will be recorded.
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy.
Incidence of Grade 3 or Higher Acute Radiation Esophagitis
Proportion of participants who develop Grade 3 or higher acute radiation esophagitis, graded according to CTCAE v5.0, from the start of radiotherapy until 3 months after completion of radiotherapy.
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy.
Incidence of Other Acute Radiation-Related Toxicities
Proportion of participants who develop other acute radiation-related toxicities, including pulmonary, cardiac, hepatic, spinal cord, and skin toxicity, graded according to CTCAE v5.0, from the start of radiotherapy until 3 months after completion of radiotherapy.
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy.
Incidence of Late Esophageal Toxicity
Proportion of participants who develop late esophageal radiation-related toxicity after completion of radiotherapy, assessed according to RTOG late toxicity criteria.
Time frame: From 3 months after completion of radiotherapy through 24 months after randomization.
Progression-Free Survival at 1 and 2 Years
Progression-free survival is defined as the time from the start of study treatment (chemoradiotherapy) to tumor recurrence/progression or last follow-up. PFS rates at 1 and 2 years will be estimated using Kaplan-Meier methods.
Time frame: From start of study treatment; assessed at 1 and 2 years.
Overall Survival
Overall survival is defined as the time from the start of study treatment (chemoradiotherapy) to death from any cause or last follow-up. Survival status will be collected through the long-term follow-up period.
Time frame: From start of study treatment through up to 24 months after randomization.
Locoregional Progression-Free Survival
Locoregional progression-free survival is defined as the time from the start of study treatment to locoregional progression/recurrence or death from any cause, whichever occurs first, or last follow-up.
Time frame: From start of study treatment through up to 24 months after randomization.
Objective Response Rate
Objective response rate is defined as the proportion of participants with a best overall response of complete response or partial response, assessed by imaging (CT/MRI/PET-CT) according to RECIST 1.1.
Time frame: From start of study treatment until disease progression/recurrence or last tumor assessment; assessed up to 24 months after randomization.
In-Field and Marginal Recurrence Rates at 1 and 2 Years
In-field recurrence is defined as tumor recurrence within the original irradiated target volume. Marginal recurrence is defined as recurrence within 1 cm outside the planning target volume (PTV) in any direction. Recurrence will be assessed by imaging and pathology when available. Cumulative rates at 1 and 2 years will be estimated.
Time frame: From start of study treatment; assessed at 1 and 2 years.
No study locations are listed for this record.
Plan to share: No — There is currently no plan to share individual participant data (IPD). The informed consent and ethics approval for this investigator-initiated trial cover study participation and publication of aggregate results, not deposition or broad sharing of individual-level data. The data include sensitive clinical, imaging, treatment-planning, and follow-up information, and sharing could compromise participant privacy and confidentiality. In addition, no data-sharing agreement, dedicated data repository, or funding for IPD curation and transfer has been established. Therefore, IPD will not be made available for secondary research.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2031, 56 months later.
Of 94 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 129. This study's planned 56 months is below that.
Counting every sponsor, half of 395 studies reached it within 44 months; a quarter within 30 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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