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

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

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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