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Not yet recruitingNCT06102161Updated Oct 26, 2023

Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)

A Phase 3 interventional study of Wedge resection in Lung Cancer, Wedge Resection and Ground-glass Opacity, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
286
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 0.25 to 0.5.

02

Conditions studied

  • Lung Cancer
  • Wedge Resection
  • Ground-glass Opacity

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03

In context

Lung Neoplasms

7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 286 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

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Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
  2. Aged from 18 to 80 years old;
  3. ECOG equals 0 or 1;
  4. Not receiving lung cancer surgery before;
  5. Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
  6. 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;
  7. 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;
  8. peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.
  9. cT1N0M0 tumors;
  10. Complete tumor resection by wedge resection as assessed by the surgeon;
  11. Not receiving chemotherapy or radiotherapy before.

Exclusion criteria

Exclusion Criteria:

  1. Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
  2. CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
  3. Cannot be completely resected by wedge resection;
  4. Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;
  5. Receiving lung cancer surgery before;
  6. Receiving radiotherapy or chemotherapy.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
286 participants (estimated)

Study arms

  • Experimental
    Wedge resection

    Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue.

    Procedure: Wedge resection

Interventions

  • ProcedureWedge resection

    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.

06

What researchers measure

Primary outcomes

  1. 5-year overall survival

    The event is defined as the death due to any causes.

    Time frame: 5 years

Secondary outcomes

  1. 5-year recurrence-free survival

    The event is defined as the tumor recurrence.

    Time frame: 5 years

  2. Postoperative lung function (FEV1)

    forced expiratory volume in one second (FEV1)

    Time frame: 5 years

  3. Postoperative lung function

    forced vital capacity (FVC)

    Time frame: 5 years

  4. Sites of tumor recurrence and metastasis

    Time frame: 5 years

  5. Radical wedge resection (R0 resection) completion rate

    Time frame: 5 years

  6. Surgery-related complications

    Time frame: 5 years

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06102161
Lead sponsor
Fudan University
Responsible party
Haiquan Chen (Director in the Department of Thoracic Surgery, FUSCC, Fudan University) — Principal investigator
First posted
Oct 26, 2023
Start date
Nov 2023 (estimated)
Primary completion
Nov 2025 (estimated)
Completion
Nov 2030 (estimated)
Last update
Oct 26, 2023

Study contacts

Tong Li
Contact
litong_medical@163.com
+86 18813039287

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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