NCT02777788

Curative Study of Chinese Traditional Medicine to Treat Lung Cancer

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	JinFuKang	treated with chemotherapy
DRUG	XingZaoRuanJian	treated with chemotherapy
DRUG	pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-05-19
• Last updated: 2017-10-10