- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889666
A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer (CCODG-NSCLC)
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 Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Weijun Ma, Ph.D
- Phone Number: 86-21-54923268
- Email: wjma@sibs.ac.cn
Study Contact Backup
- Name: Yu Sun, Ph.D
- Phone Number: 86-21-54923302
- Email: sunyu@sibs.ac.cn
Study Locations
-
-
-
Shanghai, China, 200072
- Recruiting
- Shanghai 10th People's Hospital
-
Contact:
- Da Fu, Ph.D
- Phone Number: 86-15921527578
- Email: fu800da900@126.com
-
Shanghai, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital, Tongji University School of Medicine
-
Contact:
- Chun-Yan Wu, M.D
- Phone Number: 86-65115006-3030
- Email: 51917533@qq.com
-
-
Jilin
-
Changchun, Jilin, China, 130033
- Recruiting
- China-Japan Union Hospital, Jilin University
-
Contact:
- Xian-Ling Cong, M.D
- Phone Number: 86-0431-89876626
- Email: qingzhao_jilin@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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
Collaborators
Investigators
- Principal Investigator: Yu Sun, Ph.D, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Carboplatin
- Cisplatin
- Oxaliplatin
- Gemcitabine
Other Study ID Numbers
- LCA-81472709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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