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NCT Number: NCT06031181

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

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.

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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Frozen Section Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Sublobar Resection Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Chen Haiquan, MD

CONTACT

[email protected]

+86-21 64175590 ext. 1707

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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 criteria

  • 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.

Treatment and study plan

Sublobar Resection

Procedure

Sublobar Resection includes segmentectomy and wedge resection

Primary outcomes

  1. 5-year recurrence-free survival

    Time frame: 5 years

    The event is defined as the tumor recurrence.

Secondary outcomes

  1. 5-year overall survival

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chaoqiang Deng

CONTACT

[email protected]

+86-13122677592

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Sep 11, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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