Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06542159

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

Led by Sun Yat-sen University · Updated on 2025-11-17

130

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or if surgery is refused, or PET-CT/chest CT confirmed lung oligometastases (up to 3 metastases, single lesion diameter up to 5 cm)
  • Age 18 years or older
  • ECOG performance status score of 0 to 2
  • Serum hemoglobin level of at least 80 g/L, platelets at least 100,000/µL, and absolute neutrophil count at least 1,500/µL
  • Serum creatinine no more than 1.25 times the upper normal limit or creatinine clearance at least 60 ml/min
  • Serum bilirubin no more than 1.5 times the upper normal limit, AST and ALT no more than 2.5 times the upper normal limit, alkaline phosphatase no more than 5 times the upper normal limit
  • Forced expiratory volume in 1 second (FEV1) at least 0.5 L
  • Normal CB6 range
  • Patient and family provide informed consent
Not Eligible

You will not qualify if you...

  • Tumors with bronchial invasion
  • Any condition that contraindicates radiotherapy, including active infections, recent myocardial infarction within 6 months, symptomatic heart disease such as unstable angina, congestive heart failure, or uncontrolled arrhythmias
  • Pregnant or breastfeeding women, or women without pregnancy testing
  • Substance abuse, chronic alcoholism, or AIDS
  • Uncontrollable seizures or loss of self-control due to psychiatric disorders
  • History of severe allergies or specific sensitivities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

B

Bo Qiu, Professor

CONTACT

H

Hui Liu, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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