Curative Study of Chinese Traditional Medicine to Treat Lung Cancer

Shanghai University of Traditional Chinese Medicine120 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

120

Conditions

Cancer

Interventions

JinFuKangDRUG

treated with chemotherapy

XingZaoRuanJianDRUG

treated with chemotherapy

pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Progression-Free Survival

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.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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