Lung AdenocarcinomaPhase 3NCT06031181
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)
A Phase 3 study testing Sublobar Resection in people with Lung Adenocarcinoma and Frozen Section, 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-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Adenocarcinoma, Frozen Section, Sublobar Resection
- What is being tested?
- Sublobar Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2023to 31 Dec 2030
- 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;
- Resectable peripheral cT1N0M0 tumors;
- Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
- Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
- Not receiving chemotherapy or radiotherapy before.
Who cannot join
- Not cT1N0M0;
- Cannot be completely resected by sublobar resection;
- Invasive lung adenocarcinoma or 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 Cancer Center
Shanghai, Shanghai Municipality, 200032
Chen Haiquan, MD, +86-21 64175590 ext. 1707, hqchen1@yahoo.com
About this study
Official title: Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.
- Conditions
- Lung Adenocarcinoma, Frozen Section, Sublobar Resection
- Being tested
- Sublobar Resection
- 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.
Sublobar ResectionProcedure or surgery
Sublobar Resection includes segmentectomy and wedge resection
| Study group | Role | What they receive |
|---|---|---|
| Sublobar resection | Experimental | Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section Receives: Procedure: Sublobar Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year recurrence-free survival
The event is defined as the tumor recurrence.
Measured: 5 years
Secondary outcomes (1)
5-year overall survival
The event is defined as the death due to any causes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Mar 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2030 (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 Lung AdenocarcinomaStudies 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
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031181
- Sponsor's protocol ID
- SAFROS
- Status last verified
- Dec 2023
- First submitted
- 4 Sep 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng S, Deng C, Li Y, Zhang Y, Chen H. Sublobar resection for adenocarcinoma in situ and minimally invasive adenocarcinoma diagnosed by intraoperative frozen section (ECTOP-1019): a study protocol of prospective, single-arm, multicenter, phase III study. J Thorac Dis. 2024 Sep 30;16(9):6286-6291. doi: 10.21037/jtd-24-623. Epub 2024 Sep 18.
PubMed 39444881
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial
- ClinicalTrials.gov ID
- NCT06031181
- Acronym / sponsor ID
- SAFROS
- Conditions
- Lung Adenocarcinoma, Frozen Section, Sublobar Resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Sep 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-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sublobar resection | Experimental | Procedure: Sublobar ResectionSublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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;
- Resectable peripheral cT1N0M0 tumors;
Key exclusion criteria (5 listed)
- Not cT1N0M0;
- Cannot be completely resected by sublobar resection;
- Invasive lung adenocarcinoma or 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 |
|---|---|---|
| Sublobar ResectionSublobar Resection includes segmentectomy and wedge resection | Procedure or surgery | Sublobar resection |
Primary outcome
5-year recurrence-free survival
Time frame: 5 years
The event is defined as the tumor recurrence.
1 secondary outcome
5-year overall survival
Time frame: 5 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 13 Dec 2023.
- Derived from this study: PubMed 39444881Zheng S, Deng C, Li Y, Zhang Y, Chen H. Sublobar resection for adenocarcinoma in situ and minimally invasive adenocarcinoma diagnosed by intraoperative frozen section (ECTOP-1019): a study protocol of prospective, single-arm, multicenter, phase III study. J Thorac Dis. 2024 Sep 30;16(9):6286-6291. doi: 10.21037/jtd-24-623. Epub 2024 Sep 18.
- 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.
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 Sublobar Resection in people with Lung Adenocarcinoma and Frozen Section, 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 8 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 13 Dec 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.
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 Chaoqiang Deng (+86-13122677592, fdudengcq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year recurrence-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 NCT06031181, 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 13 Dec 2023.