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

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.

Conditions

• Recurrent Non-small Cell Lung Cancer

Interventions

DRUG

Cisplatin

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.

DRUG

Carboplatin

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.

DRUG

Docetaxel

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.

DRUG

Gemcitabine/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.

DRUG

Gemcitabine/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.

DRUG

Docetaxel/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.

DRUG

Docetaxel/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.

DRUG

Placebo

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital

  collaborator OTHER

• Jilin University

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• Shanghai Tongji Hospital, Tongji University School of Medicine

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Yu Sun, Ph.D · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• China

Study Locations