Lung CancerPhase 3NCT06102161
Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)
A Phase 3 study testing Wedge resection in people with Lung Cancer and Wedge Resection, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Wedge Resection, Ground-glass Opacity
- What is being tested?
- Wedge resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Nov 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;
- Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
- 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;
Show all 11Show fewer
- The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm;
- peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.
- cT1N0M0 tumors;
- Complete tumor resection by wedge resection as assessed by the surgeon;
- Not receiving chemotherapy or radiotherapy before.
Who cannot join
- Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
- CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
- Cannot be completely resected by wedge resection;
- Invasive lung adenocarcinoma or lung malignancy other than 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.
About this study
Official title: Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial
This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.
- Conditions
- Lung Cancer, Wedge Resection, Ground-glass Opacity
- Being tested
- Wedge resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wedge resectionProcedure or surgery
Wedge resection is a surgical procedure that is done to remove a wedge-shaped section of lung tissue, usually for treating lung cancer. A wedge resection is less invasive than some of the other surgical options used to remove lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Wedge resection | Experimental | Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue. Receives: Procedure: Wedge resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
The event is defined as the death due to any causes.
Measured: 5 years
Secondary outcomes (6)
5-year recurrence-free survival
The event is defined as the tumor recurrence.
Measured: 5 years
Postoperative lung function (FEV1)
forced expiratory volume in one second (FEV1)
Measured: 5 years
Postoperative lung function
forced vital capacity (FVC)
Measured: 5 years
Sites of tumor recurrence and metastasis
Measured: 5 years
Radical wedge resection (R0 resection) completion rate
Measured: 5 years
Surgery-related complications
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 posted26 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 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 CancerStudies 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
- 286 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
- NCT06102161
- Sponsor's protocol ID
- WGGO
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Fu F, Zhang Y, Chen H. Protocol for a single-arm, multicenter, prospective, confirmatory phase III trial of wedge resection for invasive ground glass opacity-featured lung cancer with a size </=2 cm and a consolidation tumor ratio between 0.25 and 0.5 (ECTOP-1020 study). J Thorac Dis. 2024 Jul 30;16(7):4711-4718. doi: 10.21037/jtd-24-440. Epub 2024 Jul 9.
PubMed 39144343
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial
- ClinicalTrials.gov ID
- NCT06102161
- Acronym / sponsor ID
- WGGO
- Conditions
- Lung Cancer, Wedge Resection, Ground-glass Opacity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 26 Oct 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 the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wedge resection | Experimental | Procedure: Wedge resectionWedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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;
- Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
Key exclusion criteria (6 listed)
- Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
- CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
- Cannot be completely resected by wedge resection;
- Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;
- Receiving lung cancer surgery before;
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 |
|---|---|---|
| Wedge resectionWedge resection is a surgical procedure that is done to remove a wedge-shaped section of lung tissue, usually for treating lung cancer. A wedge resection is less invasive than some of the other surgical options used to remove lung cancer. | Procedure or surgery | Wedge resection |
Primary outcome
5-year overall survival
Time frame: 5 years
The event is defined as the death due to any causes.
6 secondary outcomes
5-year recurrence-free survival
Time frame: 5 years
Postoperative lung function (FEV1)
Time frame: 5 years
Postoperative lung function
Time frame: 5 years
Sites of tumor recurrence and metastasis
Time frame: 5 years
Radical wedge resection (R0 resection) completion rate
Time frame: 5 years
Surgery-related complications
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 26 Oct 2023.
- Derived from this study: PubMed 39144343Li T, Fu F, Zhang Y, Chen H. Protocol for a single-arm, multicenter, prospective, confirmatory phase III trial of wedge resection for invasive ground glass opacity-featured lung cancer with a size </=2 cm and a consolidation tumor ratio between 0.25 and 0.5 (ECTOP-1020 study). J Thorac Dis. 2024 Jul 30;16(7):4711-4718. doi: 10.21037/jtd-24-440. Epub 2024 Jul 9.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell 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.
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 Wedge resection in people with Lung Cancer and Wedge Resection, 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 11 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Oct 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 Tong Li (+86 18813039287, litong_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall 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 NCT06102161, 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 26 Oct 2023.