Thymus Dosimetric and Morphologic Predictors of Radiation-Induced Lymphopenia in Stage III NSCLC (NCT07564089) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Thymus Dosimetric and Morphologic Predictors of Radiation-Induced Lymphopenia in Stage III NSCLC
China450 participantsStarted 2026-04-10
Plain-language summary
This study is being done to find out whether features of the thymus gland can predict a common side effect of radiation therapy for lung cancer called radiation-induced lymphopenia.
We will include adults with stage III non-small cell lung cancer (NSCLC) who are scheduled to receive curative radiation therapy to the chest, with or without chemotherapy.
Before, during, and after radiation therapy, we will measure:
The dose of radiation that reaches the thymus gland (based on each patient's treatment plan)
The size and shape of the thymus gland (using CT scans taken for radiation planning)
The number of lymphocytes (a type of immune cell) in routine blood samples
The main goal is to see if certain radiation doses to the thymus, or a smaller thymus size, can predict severe lymphopenia. We will also check whether lymphopenia affects patient outcomes such as infections or survival.
This is an observational study (no added treatment or drug) - patients will receive their standard radiation therapy as planned by their doctor. The study only collects and analyzes data from standard scans and blood tests.
Potential benefits: Findings may help doctors design "immune-sparing" radiation plans in the future to reduce lymphopenia. Potential risks: There are no additional risks beyond standard radiation therapy, as this study does not change your treatment.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years;
* Pathologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) with a clinical stage of III (according to the 8th edition or latest version of the AJCC staging system);
* Eligible for radical radiotherapy or chemoradiotherapy to the chest, with a planned total dose of ≥50 Gy to the chest, using a fractionation schedule of 1.8-2.0 Gy per fraction (conventional fractionation) or a high-dose fractionation regimen permitted by the protocol;
* Planned to undergo periodic blood tests before and after radiotherapy, including absolute lymphocyte count;
* ECOG performance status of 0-2;
* Able to undergo regular follow-up and provide blood samples and imaging evaluations as required by the protocol.
Exclusion Criteria:
* Previous history of thoracic or whole-body radiation therapy;
* A diagnosis of radiation-induced lymphocytopenia or baseline lymphocytopenia graded ≥ Grade 2 (according to the CTCAE criteria) prior to study enrollment;
* Patients with a history of or known primary immunodeficiency, active autoimmune disease, long-term systemic glucocorticoid therapy (prednisone-equivalent dose \> 10 mg/day), or long-term use of immunosuppressants following organ transplantation;
* History of concurrent malignancy (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that has been treated curatively and has been recurrence-free for at least 5 years);
* Pregnant or lactating women;
* Any other condition…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severe radiation-induced lymphopenia (grade ≥3)
Timeframe: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy.
2
radiation-induced lymphopenia
Timeframe: From baseline (within 7 days before radiotherapy initiation) to 6 weeks after completion of radiotherapy. ALC is measured at least weekly during radiotherapy, at the end of radiotherapy, and at 4-6 weeks post-radiotherapy.