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

NCT ID: NCT06031181

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Adenocarcinoma Frozen Section Sublobar Resection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublobar resection

Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section

Group Type EXPERIMENTAL

Sublobar Resection

Intervention Type PROCEDURE

Sublobar Resection includes segmentectomy and wedge resection

Interventions

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Sublobar Resection

Sublobar Resection includes segmentectomy and wedge resection

Intervention Type PROCEDURE

Eligibility Criteria

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

Exclusion Criteria

1. Not cT1N0M0;
2. Cannot be completely resected by sublobar resection;
3. Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Haiquan Chen

Director in the Department of Thoracic Surgery, FUSCC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chaoqiang Deng

Role: CONTACT

Phone: +86-13122677592

Email: [email protected]

Facility Contacts

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Chen Haiquan, MD

Role: primary

References

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Zheng S, Deng C, Li Y, Zhang Y, Chen H. Sublobar resection for adenocarcinoma in situ and minimally invasive adenocarcinoma diagnosed by intraoperative frozen section (ECTOP-1019): a study protocol of prospective, single-arm, multicenter, phase III study. J Thorac Dis. 2024 Sep 30;16(9):6286-6291. doi: 10.21037/jtd-24-623. Epub 2024 Sep 18.

Reference Type DERIVED
PMID: 39444881 (View on PubMed)

Other Identifiers

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SAFROS

Identifier Type: -

Identifier Source: org_study_id