Early Lung CancerUSBRT-1NCT05802654
Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
A study testing SBRT in people with Early Lung Cancer and Stereotactic Body Radiotherapy, run by Peking University Third Hospital at 1 site in China.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Lung Cancer, Stereotactic Body Radiotherapy
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Expected survival time ≥3 months;
- Laboratory results during screening must meet the following requirements:
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- Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
- Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis.
- Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) \< on routine urine test; 2+ or 24 h urinary protein quantification \< 1g;
- International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment;
- For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first fraction of SBRT. If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested;
- Compliance with the research protocol is expected to be good.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of radiation oncology, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
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?
Read the detailed description
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. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F).
- Conditions
- Early Lung Cancer, Stereotactic Body Radiotherapy
- Being tested
- SBRT
- Keywords
- lung cancer, Stereotactic body radiotherapy (SBRT), High dose, Fraction
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving SBRT | Experimental | The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F). Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from the date of treatment to the date of disease progression or death or last follow-up.
Measured: 3 years
Secondary outcomes (2)
OS
The time from the date of treatment to the date of death or last follow-up.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single fraction of ultra-high dose SBRT
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongqing Zhuang, M.D., Study chair, Department of Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802654
- Sponsor's protocol ID
- USBRT-1
- Acronym
- USBRT-1
- Status last verified
- Jun 2023
- First submitted
- 26 Mar 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan, and Clinical Study Report will be shared with researchers for research use after permission was obtained from the study institution.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
- ClinicalTrials.gov ID
- NCT05802654
- Acronym / sponsor ID
- USBRT-1 / USBRT-1
- Conditions
- Early Lung Cancer, Stereotactic Body Radiotherapy
- Keywords
- lung cancer, Stereotactic body radiotherapy (SBRT), High dose, Fraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single fraction of ultra-high dose SBRT
| Arm | Type | Receives |
|---|---|---|
| Participants receiving SBRT | Experimental | Radiation: SBRTThe participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- Expected survival time ≥3 months;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTThe participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F). | Radiation | Participants receiving SBRT |
Primary outcome
PFS
Time frame: 3 years
The time from the date of treatment to the date of disease progression or death or last follow-up.
2 secondary outcomes
OS
Time frame: 3 years
AE
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan, and Clinical Study Report will be shared with researchers for research use after permission was obtained from the study institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongqing Zhuang, M.D. study chair
Department of Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Early Lung Cancer and Stereotactic Body Radiotherapy, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongqing Zhuang, M.D. (+861082264910, hongqingzhuang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.