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Segmentectomy for Solid-dominant Lung Cancer

ConditionsSegmentectomyLung Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this trial

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for solid-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:

* The 5-year disease-free survival of patients having solid-dominant invasive lung cancer with size of 2-3cm; * The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

CTR is not 0.5-1, or size is not 2-3cm;

Tumors could not be completely resected assed by surgeons;

Not lung adenocarcinoma diagnosed cytologically or pathologically;

Receiving lung cancer surgery before;

Trial design

Design model

Single group

Treatments tested in this trial

  • Segmentectomy

    Procedure/Surgery

    The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.

Treatment groups

277 Participants
are divided into 1 treatment group
Group A: SegmentectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

5-year disease-free survival

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

Time frame
5 years

Secondary outcomes

1

Lung function test

FEV1/FVC ratio

Time frame
Half year and one year after surgical resection
2

5-year overall survival

The event is defined as death due to any causes or last follow-up.

Time frame
5 years
3

The site of tumor recurrence and metastasis

Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded.

Time frame
From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
4

Segmentectomy completion rate

Proportion of patients who complete planned segmentectomy.

Time frame
From the beginning of the surgery to the end of the surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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