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Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study

NCT06730295•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with centrally located early-stage non-small cell lung cancer (NSCLC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0), or recurrent disease (rT1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery.
•Centrally located lung cancer.
•Age 18 years or older, regardless of gender.
•ECOG performance status score of 0-2.
•Serum hemoglobin ≥ 80 g/L, platelets ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL.
•Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml/min.
•Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
•FEV1 ≥ 0.5 L.
•Normal CB6 range.
•The patient and their family agree and sign the informed consent form.

Exclusion Criteria

•Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).
•Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.
•Individuals with substance abuse issues, chronic alcoholism, or AIDS.
•Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.
•Individuals with a history of severe allergies or specific sensitivities.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

December 10, 2024

Primary Completion Date

November 30, 2027

Completion Date

November 30, 2028

Last Updated

March 12, 2025

Enrollment

ESTIMATED participants

Conditions

Lung Cancer (NSCLC)

Interventions

Online adaptive SBRT

RADIATION

Contacts

DaQuan Wang, Dr.

CONTACT

+862087343031 wangdq@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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