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

NCT06542159 | Recruiting Phase 2

• 1 other identifier: GASTO-10116
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Adaptive Radiotherapy; Stereotactic Body Radiotherapy; Non-small Cell Lung Cancer; Lung Oligometastases; Toxicity

Keywords

Online adaptive radiotherapy; Stereotactic body radiotherapy; Non-small Cell Lung Cancer; Lung oligometastases; Toxicity

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 2 or higher respiratory toxicity

  Incidence of grade 2 or higher respiratory toxicity

  1 year

Secondary Outcomes (2)

• Objective response rate

  2 months after radiotherapy

• Local control rate

  2 year

Study Arms (2)

The study group

EXPERIMENTAL

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

The control group

ACTIVE COMPARATOR

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

Interventions

Online adaptive SBRT RADIATION

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.

The study group

Conventional SBRT RADIATION

SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired.

The control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (15)

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• Roach MC, Robinson CG, DeWees TA, Ganachaud J, Przybysz D, Drzymala R, Rehman S, Kashani R, Bradley JD. Stereotactic Body Radiation Therapy for Central Early-Stage NSCLC: Results of a Prospective Phase I/II Trial. J Thorac Oncol. 2018 Nov;13(11):1727-1732. doi: 10.1016/j.jtho.2018.07.017. Epub 2018 Jul 26.

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• Zhou S, Meng Y, Sun X, Jin Z, Feng W, Yang H. The critical components for effective adaptive radiotherapy in patients with unresectable non-small-cell lung cancer: who, when and how. Future Oncol. 2022 Oct;18(31):3551-3562. doi: 10.2217/fon-2022-0291. Epub 2022 Oct 3.

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• Snyder J, Smith B, Aubin JS, Shepard A, Hyer D. Simulating an intra-fraction adaptive workflow to enable PTV margin reduction in MRIgART volumetric modulated arc therapy for prostate SBRT. Front Oncol. 2024 Jan 8;13:1325105. doi: 10.3389/fonc.2023.1325105. eCollection 2023.

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu, Professor

CONTACT

+862087343031; qiubo@sysucc.org.cn

Hui Liu, Professor

CONTACT

+862087343031; liuhui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): April 21, 2027
• Study Completion (Estimated): April 21, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)