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
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
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
treated with chemotherapy
Other Name: JinFuKang oral liquid
treated with chemotherapy
Other Name: RuanHuaTang
- 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.
- 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 ]
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
|Study Director:||HEGEN LI||Shanghai University of Traditional Chinese Medicine|