SegmentectomyPhase 3NCT05717803
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
A Phase 3 study testing Segmentectomy in people with Segmentectomy and Lung Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Segmentectomy, Lung Adenocarcinoma
- What is being tested?
- Segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 31 Dec 2029
- Phase
- Phase 3
- 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
- Patients who sign the informed consent form and are willing to complete the study according to the plan;
- Aged from 18 to 80 years old;
- ECOG equals 0 or 1;
- Not receiving lung cancer surgery before;
- Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
- Ground glass-dominant lung nodules
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- Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;
- cN0 without distant metastasis;
- Tumors could be completely resected assed by surgeons;
- Not receiving chemotherapy or radiotherapy before.
Who cannot join
- CTR is not 0-0.5, or size is not 2-3cm;
- Tumors could not be completely resected assed by surgeons;
- Not lung adenocarcinoma diagnosed cytologically or pathologically;
- Receiving lung cancer surgery before;
- Receiving radiotherapy or chemotherapy.
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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Fangqiu Fu, M.D.
About this study
Official title: Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:
- The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm;
- The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.
- Conditions
- Segmentectomy, Lung Adenocarcinoma
- Being tested
- Segmentectomy
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SegmentectomyProcedure or surgery
Also called Segment resection, Segment removal
The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.
| Study group | Role | What they receive |
|---|---|---|
| Segmentectomy | Experimental | Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm. Receives: Procedure: Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-free survival
The event is defined as the tumor recurrence or the death due to any causes.
Measured: 5 years
Secondary outcomes (6)
Lung function test
FEV1/FVC
Measured: Half year and one year after surgical resection
5-year overall survival
The event is defined as death due to any causes or last follow-up.
Measured: 5 years
The site of tumor recurrence and metastasis
Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded.
Measured: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
Segmentectomy completion rate
Proportion of patients who complete planned segmentectomy.
Measured: From the beginning of the surgery to the end of the surgery.
Radical segmentectomy (R0 resection) completion rate
According to the postoperative pathology report of the patients, the proportion of patients with no residual tumor after radical segmentectomy accounted for all patients who underwent segmentectomy.
Measured: From surgery to the release of the final pathology report, an average of two weeks.
Surgery-related complications
such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc
Measured: From surgery to patient discharge or 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Feb 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
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 SegmentectomyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717803
- Sponsor's protocol ID
- FUSCC2211
- Status last verified
- May 2024
- First submitted
- 6 Jan 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen S, Huang Q, Fu F, Wang Z, Zhang Y, Chen H. Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2-3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012). BMJ Open. 2024 Jul 3;14(7):e087088. doi: 10.1136/bmjopen-2024-087088.
PubMed 38960464
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
- ClinicalTrials.gov ID
- NCT05717803
- Acronym / sponsor ID
- FUSCC2211
- Conditions
- Segmentectomy, Lung Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Feb 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 is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:
- The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm;
- The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy | Experimental | Procedure: SegmentectomySegmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who sign the informed consent form and are willing to complete the study according to the plan;
- Aged from 18 to 80 years old;
- ECOG equals 0 or 1;
- Not receiving lung cancer surgery before;
- Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
Key exclusion criteria (5 listed)
- CTR is not 0-0.5, or size is not 2-3cm;
- Tumors could not be completely resected assed by surgeons;
- Not lung adenocarcinoma diagnosed cytologically or pathologically;
- Receiving lung cancer surgery before;
- Receiving radiotherapy or chemotherapy.
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 |
|---|---|---|
| SegmentectomyAlso: Segment resection, Segment removalThe lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues. | Procedure or surgery | Segmentectomy |
Primary outcome
5-year disease-free survival
Time frame: 5 years
The event is defined as the tumor recurrence or the death due to any causes.
6 secondary outcomes
Lung function test
Time frame: Half year and one year after surgical resection
5-year overall survival
Time frame: 5 years
The site of tumor recurrence and metastasis
Time frame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
Segmentectomy completion rate
Time frame: From the beginning of the surgery to the end of the surgery.
Radical segmentectomy (R0 resection) completion rate
Time frame: From surgery to the release of the final pathology report, an average of two weeks.
Surgery-related complications
Time frame: From surgery to patient discharge or 30 days after surgery.
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 3 Jun 2024.
- Derived from this study: PubMed 38960464Chen S, Huang Q, Fu F, Wang Z, Zhang Y, Chen H. Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2-3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012). BMJ Open. 2024 Jul 3;14(7):e087088. doi: 10.1136/bmjopen-2024-087088.
- 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.
Haiquan Chen, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Segmentectomy in people with Segmentectomy and Lung Adenocarcinoma, run by Fudan 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fangqiu Fu, M.D. (+86-13122677592, fufangqiu12@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-free survival (time frame: 5 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 NCT05717803, 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 3 Jun 2024.