RecruitingPhase 2NCT03351842

Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

460 participants

Start Date

Sep 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.


Eligibility

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is investigating whether adding chemotherapy after surgery for early-stage lung cancer (stage I non-small cell lung cancer) that has a specific aggressive growth pattern (called micropapillary pattern, making up at least 20% of the tumor) improves outcomes compared to surgery alone. **You may be eligible if...** - Your lung cancer was completely removed by surgery and confirmed as stage I - The cancer was diagnosed as a specific type called micropapillary predominant lung adenocarcinoma - You are enrolled within 4 weeks of your surgery date - You have not had prior chemotherapy or radiation for lung cancer - You are in good overall health (performance status 0 or 1) - Women must not be pregnant or breastfeeding and must use effective contraception during the study **You may NOT be eligible if...** - You received chemotherapy or radiation before surgery - Your overall health is too poor to tolerate chemotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcis Platinum/Carboplatin, Pemetrexed Disodium

Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours

PROCEDUREUndergo surgery

Therapeutic conventional surgery, R0 resection


Locations(1)

Thoracic Surgery Department of Shanghai Pulmonary Hospital

Shanghai, China

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NCT03351842