Non-small-cell Lung Cancer (NSCLC)NCT06232967
PPIO-006 Primary Tumor Resection for IVa NSCLC
An observational study of Non-small-cell Lung Cancer (NSCLC), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The goal of this mutli-center observational study is toinvestigate the impact of primary tumor resection (PTR) on the long-term survival of patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination (DPD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small-cell Lung Cancer (NSCLC)
- What is being tested?
- Primary tumor resection or not
- Type of treatment
- Surgery or procedure
- How many people
- 223 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2016 to December 2023, a total of 204 consecutive NSCLC patients with surgically confirmed DPD were collected retrospectively from three high-volume centers in China. Data were obtained by reviewing medical records.
Who may be able to join
- pathologically confirmed primary NSCLC with malignant pleural dissemination, (2) no preoperative treatment, (3) age 80 years or younger, (4) clinicopathologic data and follow-up results were complete.
Who cannot join
- pleural effusion, contralateral lung metastasis or distant metastasis revealed preoperatively, and (2) with a history of other malignant disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Army Medical Center of the People's Liberation Army
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Long-term Outcome of Primary Tumor Resection in Non-Small-Cell Lung Cancer Patients With Dry Pleural Dissemination: A Multi-center Study
The goal of this mutli-center observational study is toinvestigate the impact of primary tumor resection (PTR) on the long-term survival of patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination (DPD). The main question it aims to answer is: whether primary tumor resection improve long-term survival of NSCLC patients with dry pleural dissemination.
Read the detailed description
Non-small-cell lung cancer (NSCLC) patients with dry pleural dissemination have poor survival rates and are generally contraindicated for surgery. Previous single-center retrospective studies have suggested that these patients may benefit from primary tumor resection (PTR). However, the evidence supporting PTR is still limited, especially in the era of targeted therapy. This study aimed to investigate the impact of PTR on the long-term survival of patients with NSCLC and DPD.
- Conditions
- Non-small-cell Lung Cancer (NSCLC)
- Being tested
- Primary tumor resection or not
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary tumor resection or notProcedure or surgery
For patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination, surgical decisions to perform exploratory thoracotomy only or primary tumor resection with wedge resection, segmentectomy, or lobectomy were based on surgeon experience and patient preference.
| Study group | Role | What they receive |
|---|---|---|
| Primary tumor resection (PTR group) | includes wedge resection, segmentectomy, or lobectomy. Receives: Procedure: Primary tumor resection or not | |
| Exploratory thoracotomy (ET group) | JSimply open and close surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific survival (DSS)
The duration from the day of surgery to the the last follow-up visit or to death specifically caused by NSCLC.
Measured: Up to 8 years
Secondary outcomes (1)
Progression-free survival (PFS)
The duration of survival with no evidence of progression of the disease.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Apr 2023
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI GUO, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Wei Guo, PhD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232967
- Sponsor's protocol ID
- Wei Guo
- Status last verified
- Jun 2024
- First submitted
- 20 Jan 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao T, Deng Y, Chen L, Sun W, Ge M, Zhao X, Chen X, Zhang L, Wang Y, He X, Pu X, He Y, Yu J, Guo W. Primary tumour resection in non-small cell lung cancer patients with pleural dissemination unexpectedly detected during operation: a two-centre retrospective cohort study. BMC Cancer. 2025 Feb 21;25(1):316. doi: 10.1186/s12885-025-13747-3.
PubMed 39984876
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Primary Tumor Resection in Non-Small-Cell Lung Cancer Patients With Dry Pleural Dissemination: A Multi-center Study
- ClinicalTrials.gov ID
- NCT06232967
- Acronym / sponsor ID
- Wei Guo
- Conditions
- Non-small-cell Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 31 Jan 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 mutli-center observational study is toinvestigate the impact of primary tumor resection (PTR) on the long-term survival of patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination (DPD). The main question it aims to answer is: whether primary tumor resection improve long-term survival of NSCLC patients with dry pleural dissemination.
Detailed description
Non-small-cell lung cancer (NSCLC) patients with dry pleural dissemination have poor survival rates and are generally contraindicated for surgery. Previous single-center retrospective studies have suggested that these patients may benefit from primary tumor resection (PTR). However, the evidence supporting PTR is still limited, especially in the era of targeted therapy. This study aimed to investigate the impact of PTR on the long-term survival of patients with NSCLC and DPD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary tumor resection (PTR group) | – | Procedure: Primary tumor resection or notincludes wedge resection, segmentectomy, or lobectomy. |
| Exploratory thoracotomy (ET group) | – | –JSimply open and close surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2016 to December 2023, a total of 204 consecutive NSCLC patients with surgically confirmed DPD were collected retrospectively from three high-volume centers in China. Data were obtained by reviewing medical records.
Key inclusion criteria (1 listed)
- pathologically confirmed primary NSCLC with malignant pleural dissemination, (2) no preoperative treatment, (3) age 80 years or younger, (4) clinicopathologic data and follow-up results were complete.
Key exclusion criteria (1 listed)
- pleural effusion, contralateral lung metastasis or distant metastasis revealed preoperatively, and (2) with a history of other malignant disease.
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 |
|---|---|---|
| Primary tumor resection or notFor patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination, surgical decisions to perform exploratory thoracotomy only or primary tumor resection with wedge resection, segmentectomy, or lobectomy were based on surgeon experience and patient preference. | Procedure or surgery | Primary tumor resection (PTR group) |
Primary outcome
Disease-specific survival (DSS)
Time frame: Up to 8 years
The duration from the day of surgery to the the last follow-up visit or to death specifically caused by NSCLC.
1 secondary outcome
Progression-free survival (PFS)
Time frame: Up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 39984876Bao T, Deng Y, Chen L, Sun W, Ge M, Zhao X, Chen X, Zhang L, Wang Y, He X, Pu X, He Y, Yu J, Guo W. Primary tumour resection in non-small cell lung cancer patients with pleural dissemination unexpectedly detected during operation: a two-centre retrospective cohort study. BMC Cancer. 2025 Feb 21;25(1):316. doi: 10.1186/s12885-025-13747-3.
- Individual participant dataSharing planned: No
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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.
Wei Guo, PhD principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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 Non-small-cell Lung Cancer (NSCLC), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific survival (DSS) (time frame: Up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232967, which also lists 1 linked publication.
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 27 Jun 2024; AzTrials last refreshed its copy on 2 Nov 2026.