Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases

November 13, 2025 updated by: Hui Liu, Sun Yat-sen University

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study

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 early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to explore the safety and efficacy of eliminating the PTV expansion margin based on online adaptive stereotactic body radiotherapy (SBRT) for early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. In this study, patients will be stratified according to whether they have primary early-stage NSCLC, then randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive online adaptive SBRT (without PTV expansion margin), while patients in the control group will receive conventional standard SBRT. After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT/chest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm).
  • 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:

  • Tumors with bronchial invasion are excluded.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The study group
Patients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.
Radiation: Online adaptive SBRT
Online adaptive SBRT (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. FBCT and 4DCT will be acquired.
Active Comparator: The control group
Patients in the control group will receive conventional standard stereotactic body radiotherapy. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired before initiating treatment at each fraction.
Radiation: Conventional SBRT
SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 2 or higher respiratory toxicity
Time Frame: 1 year
Incidence of grade 2 or higher respiratory toxicity
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 2 months after radiotherapy
Objective Response Rate (ORR) is defined as the proportion of patients whose tumor size decreases to a pre-specified value and is maintained for a certain period of time during cancer treatment. It includes the number of patients with Complete Response (CR) and Partial Response (PR) as a percentage of the total number of evaluable cases.
2 months after radiotherapy
Local control rate
Time Frame: 2 year
The control of the local lesion after treatment.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, Professor, Sun yat-sen universtiy cancer center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2024

Primary Completion (Estimated)

April 21, 2027

Study Completion (Estimated)

April 21, 2028

Study Registration Dates

First Submitted

August 4, 2024

First Submitted That Met QC Criteria

August 4, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-10116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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