A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer (CCODG-NSCLC)

April 15, 2024 updated by: Yu Sun, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.

In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weijun Ma, Ph.D
  • Phone Number: 86-21-54923268
  • Email: wjma@sibs.ac.cn

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200072
        • Recruiting
        • Shanghai 10th People's Hospital
        • Contact:
      • Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital, Tongji University School of Medicine
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recruiting
        • China-Japan Union Hospital, Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≤ 75 years with histologically proven NSCLC
  • No severe major organ dysfunction
  • WHO performance status of 0 or 1
  • No prior cancer chemotherapy
  • A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.

Exclusion Criteria:

  • Age ≥ 76
  • Severe major organ dysfunction
  • WHO performance status of >1
  • Prior cancer chemotherapy
  • Stage IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carboplatin
Carboplatin-based chemotherapy (Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Carboplatin was done for 3 cycles with 30 days after last 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.
Other Names:
  • Paraplatin
Experimental: Docetaxel
Docetaxel-based chemotherapy (Docetaxel 120mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Docetaxel was done for 3 cycles with 30 days after last 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.
Other Names:
  • Taxotere
Experimental: Gemcitabine/Cisplatin
Gemcitabine/Cisplatin-based combinational chemotherapy (Gemcitabine 200mg + Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last 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.
Other Names:
  • Gemzar/Platinol
Experimental: Cisplatin
Cisplatin-based chemotherapy (Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Cisplatin was done for 3 cycles with 30 days after last surgery.
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.
Other Names:
  • Platinol
Experimental: Docetaxel/Oxaliplatin
Docetaxel/Oxaliplatin-based chemotherapy (Docetaxel 120mg + Oxaliplatin 200mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last 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.
Other Names:
  • Taxotere/Eloxatin
Experimental: Docetaxel/Carboplatin
Docetaxel/Carboplatin-based chemotherapy (Docetaxel 120mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last 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.
Other Names:
  • Taxotere/Paraplatin
Experimental: Gemcitabine/Carboplatin
Gemcitabine/Carboplatin-based chemotherapy (Gemcitabine 200mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last 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.
Other Names:
  • Gemzar/Paraplatin
Placebo Comparator: Placebo
No Adjuvant chemotherapy using CCODG was done for patients who had previous surgery to remove the primary non-small cell lung carcinoma but subject to tumor relapse. Instead, placebo was supplied to these patients as a comparator Arm.
Drug: Placebo
Regular placebo in replacement of agent-specific chemotherapy was supplied to these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 years disease-free survival
Time Frame: 5 years
The disease-associated survival status during the 5 years post treatment will be measured. Note the information in the Outcome Measure is only study hypothesis.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 years overall survival
Time Frame: 5 years
The overall survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
5 years
5 years metastasis-free survival
Time Frame: 5 years
The metastasis-associated survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai 10th People's Hospital
Jiangxi Provincial Cancer Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Jilin University

Investigators

  • Principal Investigator: Yu Sun, Ph.D, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimated)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCA-81472709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes, there is plan to make individual participant data (IPD) available. According to the medical administration committee of our hospitals, these data will be made generally public upon the completion of the primary studies (anticipated to be July, 2017).

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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