NCT07908732Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 25 Oct 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 30 Jun 2031
- Lead sponsor
- Ruijin Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07908732
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 140
- From 30 Oct 2026 to the primary completion date, 30 Jun 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thoracic radiotherapy.
- Prior esophageal surgery or severe esophageal disease (e.g., achalasia, esophageal stricture, esophageal fistula).
Other illness
- Severe non-malignant comorbidities that would affect the delivery of radiotherapy.
- History of active autoimmune disease, or current use of high-dose corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressive agents.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.
Other
- Metastatic (stage IV) NSCLC.
- Pregnant or breastfeeding women.
- Grade ≥2 esophagitis before randomization.
Who the study is looking for
- 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).
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.