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Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

ConditionsEarly Lung CancerStereotactic Body Radiotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. The main questions it aims to answer are:

How effective is this regimen of SBRT for early lung cancer? How safe is this regimen of SBRT for early lung cancer?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent;

Male or female aged ≥ 18 years and ≤ 75 years;

patients with early stage lung cancer confirmed by pathology or clinical MDT;

The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 ~ 1;

Disqualifiers

currently participating in an interventional clinical trial;

any unstable systemic disease, including but not limited to active infection, congestive heart failure [New York Heart Association (NYHA) class ≥ II], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure;

other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;

women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period;

Trial design

Design model

Single group

Treatments tested in this trial

  • SBRT

    Radiation

    The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Participants receiving SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

The time from the date of treatment to the date of disease progression or death or last follow-up.

Time frame
3 years

Secondary outcomes

1

OS

The time from the date of treatment to the date of death or last follow-up.

Time frame
3 years
2

AE

The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), immune-related AE (irAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: