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

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Fudan University

Status and phase

Not yet enrolling
Phase 3

Conditions

Ground-glass Opacity
Wedge Resection
Lung Cancer

Treatments

Procedure: Wedge resection

Study type

Interventional

Funder types

Other

Identifiers

NCT06102161
WGGO

Details and patient eligibility

About

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.

Enrollment

286 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

286 participants in 1 patient group

Wedge resection
Experimental group
Description:
Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue.
Treatment:
Procedure: Wedge resection

Trial contacts and locations

0

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Central trial contact

Tong Li

Data sourced from clinicaltrials.gov

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