RecruitingPhase 1NCT02889666

A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer

A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

500 participants

Start Date

Jan 1, 2008

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares chemotherapy followed by surgery versus surgery alone for non-small cell lung cancer (the most common type of lung cancer) that has come back after being treated, to see which approach leads to better survival. **You may be eligible if...** - You are 75 years old or younger - You have been diagnosed with non-small cell lung cancer (confirmed by biopsy) - You are in good physical condition (able to perform normal daily activities) - You have not previously received chemotherapy for this cancer - Your cancer has not spread to distant parts of the body **You may NOT be eligible if...** - You are 76 years old or older - You have already received chemotherapy for lung cancer - You have serious problems with your heart, lungs, kidneys, or other major organs - Your cancer has spread to distant locations This trial aims to determine whether adding chemotherapy before surgery improves survival for recurrent lung cancer. 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

DRUGCisplatin

Procedure: Preoperative chemotherapy using Cisplatin (60mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGCarboplatin

Procedure: Preoperative chemotherapy using Carboplatin (400mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGDocetaxel

Procedure: Preoperative chemotherapy using Docetaxel (120mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGGemcitabine/Carboplatin

Procedure: Preoperative chemotherapy using Gemcitabine (200mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGGemcitabine/Cisplatin

Procedure: Preoperative chemotherapy using Gemcitabine (200mg) and Cisplatin (60mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGDocetaxel/Oxaliplatin

Procedure: Preoperative chemotherapy using Docetaxel (120mg) and Oxaliplatin (200mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGDocetaxel/Carboplatin

Procedure: Preoperative chemotherapy using Docetaxel (120mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.

DRUGPlacebo

Regular placebo in replacement of agent-specific chemotherapy was supplied to these patients.


Locations(3)

China-Japan Union Hospital, Jilin University

Changchun, Jilin, China

Shanghai 10th People's Hospital

Shanghai, China

Shanghai Pulmonary Hospital, Tongji University School of Medicine

Shanghai, China

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NCT02889666


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