NSCLCNCT06317324
Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
An observational study of NSCLC and Radiotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are: 1. Explore the survival differences. 2. Explore of the lung function changes before and after different treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Radiotherapy, Surgery
- What is being tested?
- Different treatments
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically diagnosed cIB-IIIB stage (cT2-3N0M0) NSCLC patients and tumor invades Interlobular pleura.
Who may be able to join
- Voluntarily participate and sign an informed consent form in writing;
- Age 18 and above, regardless of gender;
- Diagnosed as primary lung cancer through imaging/pathology, meeting the indications for SBRT and surgical treatment;
- The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology;
- Imaging diagnosis of NSCLC patients with tumor invasion of interlobular pleura;
- No serious abnormalities in the blood system, heart, lungs, liver, kidney function, or immune deficiency;
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- There are no restrictions on surgical methods, and both VATS and open chest surgery are acceptable;
- Physical condition score ECOG level 0-2;
- Expected survival time>3 months.
Who cannot join
- Pathological confirmation of small cell lung cancer;
- Non solitary lung cancer, non primary lung cancer, with distant metastasis;
- Individuals with a history of severe lung or heart disease;
- Severe comorbidities, such as uncontrolled hypertension, heart failure, etc;
- Pregnant or lactating women;
- Previous history of malignant tumors;
- Refusal or inability to sign the informed consent form for participating in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
Tianjin, Tianjin Municipality, 300060
Zhao Yan, +86-22-23340123 ext. 5509, yanzhaotj@126.com
Xishan Hao, M.D.
About this study
Official title: A Prospective, Single Center, Observational Study:Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:
- Explore the survival differences.
- Explore of the lung function changes before and after different treatments.
Read the detailed description
Main purpose:
Explore the survival differences between SBRT and surgery for NSCLC patients with interlobular pleural invasion.
Secondary purpose:
- Longitudinal exploration of the differences in heart and lung function changes before and after treatment between SBRT and surgery of NSCLC patients with interlobular pleural invasion
- Longitudinal exploration of dynamic changes in lung lobe volume before and after treatment in NSCLC patients with interlobular pleural invasion treated with SBRT and surgical intervention.
- Conditions
- NSCLC, Radiotherapy, Surgery
- Being tested
- Different treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different treatmentsOther
NSCLC patients receive the treatment of SBRT
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Diagnosed as primary lung cancer by imaging/pathology, meeting the indications for surgical treatment; The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology. | |
| SBRT Group | Diagnosed as primary lung cancer by imaging/pathology, meeting the indications for SBRT treatment; The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology. Receives: Other: Different treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: 3 years
PFS
Progression Free Survival
Measured: 3 years
MRFS
Distant Metatasis Free Survival
Measured: 3 years
LRFS
Local Relapse Free Survival
Measured: 3 years
Secondary outcomes (5)
VC
Vital Capacity
Measured: 1 year
FVC
Forced Vital Capacity
Measured: 1 year
FEV1
Forced Expiratory Volume in one second
Measured: 1 year
DLCO
Diffusing Capacity of the lungs for carbon monoxide
Measured: 1 year
PFR
Pulmonary Function Report
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317324
- Sponsor's protocol ID
- bc2023200
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Observational Study:Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
- ClinicalTrials.gov ID
- NCT06317324
- Acronym / sponsor ID
- bc2023200
- Conditions
- NSCLC, Radiotherapy, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Mar 2024 (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 observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:
- Explore the survival differences.
- Explore of the lung function changes before and after different treatments.
Detailed description
Main purpose:
Explore the survival differences between SBRT and surgery for NSCLC patients with interlobular pleural invasion.
Secondary purpose:
- Longitudinal exploration of the differences in heart and lung function changes before and after treatment between SBRT and surgery of NSCLC patients with interlobular pleural invasion
- Longitudinal exploration of dynamic changes in lung lobe volume before and after treatment in NSCLC patients with interlobular pleural invasion treated with SBRT and surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | – | –Diagnosed as primary lung cancer by imaging/pathology, meeting the indications for surgical treatment; The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology. |
| SBRT Group | – | Other: Different treatmentsDiagnosed as primary lung cancer by imaging/pathology, meeting the indications for SBRT treatment; The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically diagnosed cIB-IIIB stage (cT2-3N0M0) NSCLC patients and tumor invades Interlobular pleura.
Key inclusion criteria (9 listed)
- Voluntarily participate and sign an informed consent form in writing;
- Age 18 and above, regardless of gender;
- Diagnosed as primary lung cancer through imaging/pathology, meeting the indications for SBRT and surgical treatment;
- The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology;
- Imaging diagnosis of NSCLC patients with tumor invasion of interlobular pleura;
Key exclusion criteria (7 listed)
- Pathological confirmation of small cell lung cancer;
- Non solitary lung cancer, non primary lung cancer, with distant metastasis;
- Individuals with a history of severe lung or heart disease;
- Severe comorbidities, such as uncontrolled hypertension, heart failure, etc;
- Pregnant or lactating women;
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 |
|---|---|---|
| Different treatmentsNSCLC patients receive the treatment of SBRT | Other | SBRT Group |
Primary outcome
OS
Time frame: 3 years
Overall Survival
PFS
Time frame: 3 years
Progression Free Survival
MRFS
Time frame: 3 years
Distant Metatasis Free Survival
LRFS
Time frame: 3 years
Local Relapse Free Survival
5 secondary outcomes
VC
Time frame: 1 year
FVC
Time frame: 1 year
FEV1
Time frame: 1 year
DLCO
Time frame: 1 year
PFR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
Tianjin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and Radiotherapy, run by Tianjin Medical University Cancer Institute and 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 3 years). The study lists 4 primary outcomes in all. 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 19 Mar 2024.