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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06031181
Enrollment
390
Registered
2023-09-11
Start date
2023-03-31
Completion date
2030-12-31
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen Section, Lung Adenocarcinoma, Sublobar Resection

Brief 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.

Interventions

Sublobar Resection includes segmentectomy and wedge resection

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
5-year recurrence-free survival5 yearsThe event is defined as the tumor recurrence.

Secondary

MeasureTime frameDescription
5-year overall survival5 yearsThe event is defined as the death due to any causes.

Countries

China

Contacts

Primary ContactChaoqiang Deng
fdudengcq@163.com+86-13122677592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026