Non-Small Cell Lung CancerPhase 3ES-SPARENCT07908732
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
A Phase 3 study testing Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT and Standard IMRT/VMAT Without Active Esophageal Avoidance in people with Non-Small Cell Lung Cancer, run by Ruijin Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT and Standard IMRT/VMAT Without Active Esophageal Avoidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years and ≤80 years.
- Voluntary participation with written informed consent obtained before any study-related procedure.
- Pathologically confirmed non-small cell lung cancer (NSCLC).
- Locally advanced NSCLC that is unresectable or for which the patient refuses surgery.
- Planned definitive concurrent or sequential chemoradiotherapy with or without immunotherapy (prescribed dose 60-66 Gy in 30-33 fractions).
- Planning target volume (PTV) within ≤5 mm of the esophagus (i.e., the esophagus lies within the PTV expansion).
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- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Adequate bone marrow, hepatic, and renal function.
- Adequate pulmonary function: forced expiratory volume in 1 second (FEV1) ≥50% of predicted and diffusing capacity of the lung for carbon monoxide (DLCO) ≥60% of predicted.
- Expected survival ≥6 months.
Who cannot join
- Metastatic (stage IV) NSCLC.
- Prior thoracic radiotherapy.
- Pregnant or breastfeeding women.
- Severe non-malignant comorbidities that would affect the delivery of radiotherapy.
- Prior esophageal surgery or severe esophageal disease (e.g., achalasia, esophageal stricture, esophageal fistula).
- History of active autoimmune disease, or current use of high-dose corticosteroids (>10 mg/day prednisone equivalent) or immunosuppressive agents.
- Grade ≥2 esophagitis before randomization.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT, Standard IMRT/VMAT Without Active Esophageal Avoidance
- Keywords
- Non-Small Cell Lung Cancer, Esophagus-Sparing Radiotherapy, Acute Radiation Esophagitis, Intensity-Modulated Radiotherapy, Radiation Toxicity, Phase III Randomized Trial
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-Adapted Segmental Esophagus-Sparing IMRT/VMATRadiation
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 AvoidanceRadiation
Also called Standard Radiotherapy Plan
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.
| Study group | Role | What they receive |
|---|---|---|
| Risk-Adapted Segmental Esophagus-Sparing Radiotherapy | Experimental | 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. Receives: Radiation: Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT |
| Standard IMRT/VMAT Without Active Esophageal Avoidance | Active comparator | 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. Receives: Radiation: Standard IMRT/VMAT Without Active Esophageal Avoidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of radiotherapy to 3 months after completion of radiotherapy (approximately 4.5-5 months after radiotherapy initiation)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of study treatment; assessed at 1 and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baotou Cancer Hospital, The First Affiliated Hospital of Qiqihar Medical University, Linfen No.4 People's Hospital, Qinghai People's Hospital, Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital, Qianxinan Prefecture People's Hospital, Guizhou
- Responsible party
- Principal investigator, QI WEIXIANG，MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908732
- Sponsor's protocol ID
- 2026-830
- Acronym
- ES-SPARE
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07908732
- Acronym / sponsor ID
- ES-SPARE / 2026-830
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Esophagus-Sparing Radiotherapy, Acute Radiation Esophagitis, Intensity-Modulated Radiotherapy, Radiation Toxicity, Phase III Randomized Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Baotou Cancer Hospital, The First Affiliated Hospital of Qiqihar Medical University, Linfen No.4 People's Hospital, Qinghai People's Hospital, Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital, Qianxinan Prefecture People's Hospital, Guizhou
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk-Adapted Segmental Esophagus-Sparing Radiotherapy | Experimental | Radiation: Risk-Adapted Segmental Esophagus-Sparing IMRT/VMATParticipants 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. |
| Standard IMRT/VMAT Without Active Esophageal Avoidance | Active comparator | Radiation: Standard IMRT/VMAT Without Active Esophageal AvoidanceParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged ≥18 years and ≤80 years.
- Voluntary participation with written informed consent obtained before any study-related procedure.
- Pathologically confirmed non-small cell lung cancer (NSCLC).
- Locally advanced NSCLC that is unresectable or for which the patient refuses surgery.
- Planned definitive concurrent or sequential chemoradiotherapy with or without immunotherapy (prescribed dose 60-66 Gy in 30-33 fractions).
Key exclusion criteria (8 listed)
- Metastatic (stage IV) NSCLC.
- Prior thoracic radiotherapy.
- Pregnant or breastfeeding women.
- Severe non-malignant comorbidities that would affect the delivery of radiotherapy.
- Prior esophageal surgery or severe esophageal disease (e.g., achalasia, esophageal stricture, esophageal fistula).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-Adapted Segmental Esophagus-Sparing IMRT/VMATExternal-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. | Radiation | Risk-Adapted Segmental Esophagus-Sparing Radiotherapy |
| Standard IMRT/VMAT Without Active Esophageal AvoidanceAlso: Standard Radiotherapy PlanExternal-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. | Radiation | Standard IMRT/VMAT Without Active Esophageal Avoidance |
Primary outcome
Incidence of Grade 2 or Higher Acute Radiation Esophagitis (CTCAE v5.0)
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy (approximately 4.5-5 months after radiotherapy initiation)
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.
9 secondary outcomes
Incidence of Any-Grade Acute Radiation Esophagitis
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy.
Incidence of Grade 3 or Higher Acute Radiation Esophagitis
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy.
Incidence of Other Acute Radiation-Related Toxicities
Time frame: From start of radiotherapy to 3 months after completion of radiotherapy.
Incidence of Late Esophageal Toxicity
Time frame: From 3 months after completion of radiotherapy through 24 months after randomization.
Progression-Free Survival at 1 and 2 Years
Time frame: From start of study treatment; assessed at 1 and 2 years.
Overall Survival
Time frame: From start of study treatment through up to 24 months after randomization.
Locoregional Progression-Free Survival
Time frame: From start of study treatment through up to 24 months after randomization.
Objective Response Rate
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
Time frame: From start of study treatment; assessed at 1 and 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risk-Adapted Segmental Esophagus-Sparing IMRT/VMAT and Standard IMRT/VMAT Without Active Esophageal Avoidance in people with Non-Small Cell Lung Cancer, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weixiang Qi, Dr. (+86-021-64370045, qiweixiang1113@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 2 or Higher Acute Radiation Esophagitis (CTCAE v5.0) (time frame: From start of radiotherapy to 3 months after completion of radiotherapy (approximately 4.5-5 months after radiotherapy initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.