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

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ClinicalTrials.gov Identifier: NCT02889666
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Shanghai 10th People's Hospital
Jilin University
Jiangxi Provincial Cancer Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Information provided by (Responsible Party):
Yu Sun, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Non-small Cell Lung Cancer Drug: Cisplatin Drug: Carboplatin Drug: Docetaxel Drug: Gemcitabine/Carboplatin Drug: Gemcitabine/Cisplatin Drug: Docetaxel/Oxaliplatin Drug: Docetaxel/Carboplatin Drug: Placebo Phase 1

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889666


Contacts
Contact: Yu Sun, Ph.D 86-21-54923302 sunyu@sibs.ac.cn
Contact: Weijun Ma, Ph.D 86-21-54923268 wjma@sibs.ac.cn

Locations
China, Jilin
China-Japan Union Hospital, Jilin University Recruiting
Changchun, Jilin, China, 130033
Contact: Xian-Ling Cong, M.D    86-0431-89876626    qingzhao_jilin@126.com   
China
Shanghai 10th People's Hospital Recruiting
Shanghai, China, 200072
Contact: Da Fu, Ph.D    86-15921527578    fu800da900@126.com   
Shanghai Pulmonary Hospital, Tongji University School of Medicine Recruiting
Shanghai, China, 200433
Contact: Chun-Yan Wu, M.D    86-65115006-3030    51917533@qq.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai 10th People's Hospital
Jilin University
Jiangxi Provincial Cancer Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Investigators
Principal Investigator: Yu Sun, Ph.D Shanghai Jiao Tong University School of Medicine

Responsible Party: Yu Sun, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02889666     History of Changes
Other Study ID Numbers: LCA-81472709
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

Keywords provided by Yu Sun, Shanghai Jiao Tong University School of Medicine:
relapsed
non-small cell lung cancer
cisplatin
carboplatin
oxaliplatin
docetaxel
gemcitabine

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Docetaxel
Oxaliplatin
Cisplatin
Carboplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators