Curative Study of Chinese Traditional Medicine to Treat Lung Cancer

Cancer Clinical Trial

— TCM  

Official title:

Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02777788
• Other study ID #: ZY3-CCCX-3-3023
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: May 9, 2016
• Last updated: October 6, 2017
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: May 2017
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Pathologically or cytologically confirmed of stage ?b-? 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• JinFuKang
treated with chemotherapy
• XingZaoRuanJian
treated with chemotherapy
• pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin?cis-platinum or nedaplatin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of randomization until the date of first documented progression or date of death from any cause,up to 2 months
Secondary	Objective response rate		up to 2 months
Secondary	Time-to-Progression		up to 2 months
Secondary	Number of participants with treatment-related quality of life as assessed by FACT-L4.0		21 days