Health TrialsbyHealthPanel

Primary Tumor Resection for M1a Stage Lung Cancer

ConditionsLung Cancer MetastaticSurgical Resection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFudan University

About this trial

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;

Aged 18-80 years (including critical values) when signing the informed consent form;

ECOG score 0 or 1;

No previous lung cancer surgery;

Disqualifiers

The lesion cannot be completely removed surgically;

Cytological or histological pathology confirms other lung malignancies other than lung cancer;

Patients who have undergone lung cancer surgery before;

Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.

Trial population

This clinical trial is a single-arm, multicenter, prospective, confirmatory phase II clinical study, which mainly evaluates the efficacy and safety of primary lesion resection for patients with M1a stage lung cancer who have occult pleural dissemination during surgery (Figure 1). Since it is unethical not to perform primary lesion resection during surgery for such patients, this study is a single-arm one. Primary lesion resection should be a resection that can completely remove the primary lesion, including lobectomy and sublobar resection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Median overall survival

Median overall survival for M1a patients underging surgery.

Time frame
About 10months.

Secondary outcomes

1

2-year overall survival

2-year overall survival

Time frame
2 years
2

5-year overall survival

5-year overall survival

Time frame
5 years
3

FEV1 and FVC

Preoperative lung function test

Time frame
0.5 year

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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