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

Last updated: October 25, 2023
Sponsor: Fudan University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lung Disease

Cancer

Lung Cancer

Treatment

Wedge resection

Clinical Study ID

NCT06102161
WGGO
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who sign the informed consent form and are willing to complete the studyaccording 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 multiplelung 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

Exclusion Criteria:

  1. Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasiveadenocarcinoma.
  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 adenocarcinomadiagnosed cytologically or pathologically;
  5. Receiving lung cancer surgery before;
  6. Receiving radiotherapy or chemotherapy.

Study Design

Total Participants: 286
Treatment Group(s): 1
Primary Treatment: Wedge resection
Phase: 3
Study Start date:
November 01, 2023
Estimated Completion Date:
November 30, 2030

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Site Not Available

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