Curative Study of Chinese Traditional Medicine to Treat Lung Cancer (TCM)
Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
Study Overview
Status
Conditions
Detailed Description
Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer.
The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged.
The primary end point is: Objective response rate;
The secondary end points are:
- progression-free survival(PFS);
- overall survival(OS);
- Time to Progression (TTP);
- quality of life questionnaire（QOL);
- other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time.
The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on enhancing Objective response rate，prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC
- Ages Eligible for Study: 18-65 years old;
- Physical status score (ECOG PS) ≤ 2 scores；
- Estimated life expectancy of at least 6 months；
- Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥80*109/L, Liver and kidney function is normal;
- Informed consent from the patient.
Exclusion Criteria:
- Patient with other malignant tumor except NSCLC 5 years previous to study entry.
- Patients who have received targeted drug treatment；
- Serious problem of heart, liver or kidney with severe dysfunction;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
- Participating in other drug trials;
- Who are allergic to the study drug.
- Diabetic patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: chemotherapy
Eligible subjects will be treated with platinum-doublet 2 cycles chemotherapy:pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin. Each cycle was 21-days. Dosage:pemetrexed i.v.500mg/m2 d1 ; docetaxel i.v.75mg/m2 d1 ; gemcitabine i.v.1250 mg/m2 d1,d8 ; paclitaxel i.v.175mg/m2 d1 ; vinorelbine i.v.25mg/m2 d1,d8; carboplatin i.v.area under curve (AUC) 5 d1 ；cis-platinum i.v.75mg/m2 d1（or divided into 3days）；nedaplatin i.v.80mg/m2 d1. |
|
|
EXPERIMENTAL: TCM combined chemotherapy
TCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same.
JinFuKang po.tid.30ml
d6-d21 XingZaoRuanJian po.tid.30ml
d6-d21
|
treated with chemotherapy
Other Names:
treated with chemotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months
|
The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer.
|
From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response rate
Time Frame: up to 2 months
|
up to 2 months
|
|
Time-to-Progression
Time Frame: up to 2 months
|
up to 2 months
|
|
Number of participants with treatment-related quality of life as assessed by FACT-L4.0
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
Investigators
- Study Director: HEGEN LI, Shanghai University of Traditional Chinese Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Folic Acid Antagonists
- Gemcitabine
- Docetaxel
- Carboplatin
- Paclitaxel
- Cisplatin
- Vinorelbine
- Pemetrexed
- Nedaplatin
Other Study ID Numbers
- ZY3-CCCX-3-3023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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