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Curative Study of Chinese Traditional Medicine to Treat Lung Cancer (TCM)

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ClinicalTrials.gov Identifier: NCT02777788
Recruitment Status : Unknown
Verified May 2017 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2016
Last Update Posted : October 10, 2017
Sponsor:
Collaborators:
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Brief Summary:
The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.

Condition or disease Intervention/treatment Phase
Cancer Drug: JinFuKang Drug: XingZaoRuanJian Drug: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin Phase 2 Phase 3

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:

  1. progression-free survival(PFS);
  2. overall survival(OS);
  3. Time to Progression (TTP);
  4. quality of life questionnaire(QOL);
  5. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.

Drug: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
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
Drug: JinFuKang
treated with chemotherapy
Other Name: JinFuKang oral liquid

Drug: XingZaoRuanJian
treated with chemotherapy
Other Name: RuanHuaTang




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: up to 2 months ]
  2. Time-to-Progression [ Time Frame: up to 2 months ]
  3. Number of participants with treatment-related quality of life as assessed by FACT-L4.0 [ Time Frame: 21 days ]


Information from the National Library of Medicine

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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:

  1. Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC
  2. Ages Eligible for Study: 18-65 years old;
  3. Physical status score (ECOG PS) ≤ 2 scores;
  4. Estimated life expectancy of at least 6 months;
  5. 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;
  6. Informed consent from the patient.

Exclusion Criteria:

  1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.
  2. Patients who have received targeted drug treatment;
  3. Serious problem of heart, liver or kidney with severe dysfunction;
  4. Pregnant or child breast feeding women;
  5. Mental or cognitive disorders;
  6. Participating in other drug trials;
  7. Who are allergic to the study drug.
  8. Diabetic patients.

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): NCT02777788


Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Study Director: HEGEN LI Shanghai University of Traditional Chinese Medicine
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02777788    
Other Study ID Numbers: ZY3-CCCX-3-3023
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Chinese Traditional Medicine
Additional relevant MeSH terms:
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Gemcitabine
Paclitaxel
Vinorelbine
Docetaxel
Carboplatin
Pemetrexed
Cisplatin
Nedaplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors