IA Lung AdenocarcinomaNCT05983835
Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
A study testing Patients receive subsegmentectomy in people with IA Lung Adenocarcinoma and Combined Segmentectomy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
This project intends to include stage IA lung adenocarcinoma patients with CT imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- IA Lung Adenocarcinoma, Combined Segmentectomy
- What is being tested?
- Patients receive subsegmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 688 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2025
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) , Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any induction therapy; (6) PS score of 0-1, without severe complications, and functional status tolerant to minimally invasive lobectomy.
- FEV1≥1L was assessed by pulmonary function test and was greater than 50% of the predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant metastasis were found in the preoperative clinical evaluation, (9) voluntary participation and informed consent were obtained;
Who cannot join
- (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was located in 1/3 of the lung field, and combined segmental resection may not meet the requirement of resection margin (3) multiple GGO considered multiple primary lung cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary lesion that may require surgical treatment in the next 5 years (4) high risk patients with severe other organ diseases, (5) history of other malignant tumors within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe mental disorders, (10) with a history of unstable angina or myocardial infarction within 6 months, and severe stenosis of the major branches of the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a history of continuous systemic corticosteroid therapy within 1 month, and (13) according to the judgment of the investigators, the patients were not suitable to be included in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
This project intends to include stage IA lung adenocarcinoma patients with CT imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups.
- Conditions
- IA Lung Adenocarcinoma, Combined Segmentectomy
- Being tested
- Patients receive subsegmentectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients receive subsegmentectomyProcedure or surgery
Patients receive lobectomy
| Study group | Role | What they receive |
|---|---|---|
| combined segmentectomy | Experimental | Not described Receives: Procedure: Patients receive subsegmentectomy |
| lobectomy | Placebo comparator | Not described Receives: Procedure: Patients receive subsegmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IA Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983835
- Sponsor's protocol ID
- Union-01
- Status last verified
- Oct 2022
- First submitted
- 2 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05983835
- Acronym / sponsor ID
- Union-01
- Conditions
- IA Lung Adenocarcinoma, Combined Segmentectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Aug 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.
This project intends to include stage IA lung adenocarcinoma patients with CT imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined segmentectomy | Experimental | Procedure: Patients receive subsegmentectomy |
| lobectomy | Placebo comparator | Procedure: Patients receive subsegmentectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) , Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any induction therapy; (6) PS score of 0-1, without severe complications, and functional status tolerant to minimally invasive lobectomy.
Key exclusion criteria (1 listed)
- (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was located in 1/3 of the lung field, and combined segmental resection may not meet the requirement of resection margin (3) multiple GGO considered multiple primary lung cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary lesion that may require surgical treatment in the next 5 years (4) high risk patients with severe other organ diseases, (5) history of other malignant tumors within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe mental disorders, (10) with a history of unstable angina or myocardial infarction within 6 months, and severe stenosis of the major branches of the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a history of continuous systemic corticosteroid therapy within 1 month, and (13) according to the judgment of the investigators, the patients were not suitable to be included in the trial.
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 |
|---|---|---|
| Patients receive subsegmentectomyPatients receive lobectomy | Procedure or surgery | combined segmentectomy, lobectomy |
Primary outcome
Disease-Free Survival
Time frame: 2 years
This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
Related trials for IA Lung Adenocarcinoma
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Not yet recruitingPhase 1
Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation
Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 1/2
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
Non Small Cell Lung Cancer, Advanced Solid Tumor
RecruitingPhase 1
Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies
Advanced Cancers (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Mets) With Specific Mutations (Homologous Recombination Deficiency)
Active, not recruiting
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients receive subsegmentectomy in people with IA Lung Adenocarcinoma and Combined Segmentectomy, run by Fujian Medical University Union 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 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 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. Some participants in this study may receive a placebo. 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?
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-Free Survival (time frame: 2 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 9 Aug 2023.