RecruitingPhase 3NCT06031181

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial


Sponsor

Fudan University

Enrollment

390 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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;
  • Resectable peripheral cT1N0M0 tumors;
  • 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;
  • Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
  • Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria5

  • Not cT1N0M0;
  • Cannot be completely resected by sublobar resection;
  • Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically;
  • Receiving lung cancer surgery before;
  • Receiving radiotherapy or chemotherapy.

Interventions

PROCEDURESublobar Resection

Sublobar Resection includes segmentectomy and wedge resection


Locations(1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06031181


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