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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

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE May 19, 2016
Last Update Posted Date October 10, 2017
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
  • Objective response rate [ Time Frame: up to 2 months ]
  • Time-to-Progression [ Time Frame: up to 2 months ]
  • Number of participants with treatment-related quality of life as assessed by FACT-L4.0 [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curative Study of Chinese Traditional Medicine to Treat Lung Cancer
Official Title  ICMJE Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: JinFuKang
    treated with chemotherapy
    Other Name: JinFuKang oral liquid
  • Drug: XingZaoRuanJian
    treated with chemotherapy
    Other Name: RuanHuaTang
  • Drug: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
Study Arms  ICMJE
  • 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.

    Intervention: 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
    Interventions:
    • Drug: JinFuKang
    • Drug: XingZaoRuanJian
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02777788
Other Study ID Numbers  ICMJE ZY3-CCCX-3-3023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shanghai University of Traditional Chinese Medicine
Study Sponsor  ICMJE Shanghai University of Traditional Chinese Medicine
Collaborators  ICMJE
  • Shanghai Chest Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China
Investigators  ICMJE
Study Director: HEGEN LI Shanghai University of Traditional Chinese Medicine
PRS Account Shanghai University of Traditional Chinese Medicine
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP