NCT07412327

Brief Summary

This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (AJCC eighth edition staging) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
38mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Feb 2026Jul 2029

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Early-Stage Lung CancerLung Cancer

Keywords

Proton therapyhypofractionated radiotherapyradiotherapyEarly-Stage Lung Cancerlung cancerSBPT

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    Progression Free Survival is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method

    Up to 3 years

Secondary Outcomes (5)

  • Overall Survival

    UP to 3 years

  • Local Control Rate

    Up to 3 years

  • Quality of life scores

    Up to 3 years

  • Quality of life scores

    Up to 3 years

  • Rate of grade 3-5 adverse events

    Up to 3 years

Study Arms (1)

Stereotactic Body Proton Therapy

EXPERIMENTAL

The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.

Radiation: Stereotactic Body Proton Therapy

Interventions

Stereotactic Body Proton TherapyRADIATION

They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.

Also known as: SBPT
Stereotactic Body Proton Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after MDT discussion.
  • The clinical staging based on PET-CT examination is: cT1\~3 N0M0, stage IA-IIB (AJCC eighth edition).
  • Age: 18 years and above.
  • KPS score ≥60.
  • The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
  • Relatively good organ function:
  • Normal bone marrow function: WBC≥3×109/L, Platelet ≥80×109/L, HGB≥90g/L
  • Normal liver and kidney function:
  • Total bilirubin, AST, and ALT≤2.0×upper limit of normal values;
  • Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
  • The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

  • Patients with other malignant tumors.
  • Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
  • Those whose laboratory test values do not meet relevant standards before enrollment.
  • Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
  • Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Concord Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

CN(1)