Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||State Administration of Traditional Chinese Medicine of Shanghai|
- quality of life（QoL) [ Time Frame: every three weeks ] [ Designated as safety issue: No ]
- two-year disease-free survival rate and disease-free survival [ Time Frame: once every three months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Chemotherapy + TCM group
The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.
Prescriptions formulated into granules origin from Professor Liu Jiaxiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe . Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.
three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
Other Name: Prescriptions from Professor Liu Jiaxiang
Placebo Comparator: Chemotherapy + placebo group
The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.we compromise the raw materials for the placebo including 10% of Chinese medicine, food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.
At present the high rate of recurrence and metastasis of postoperative non-small cell lung cancer (NSCLC) patients is one of the leading causes resulting in failure of treating lung cancer. More than 35% of postoperative lung cancer patients with stage I died in 5 years due to recurrence or metastasis; the 5-year survival rates of stage II, IIIa, IIIb were 31%, 17.9% and 11.7% respectively. The survival rate was improved by 5% with adjuvant chemotherapy after resection, so regimen consist of platinum-based two chemical medicines are commended as the adjuvant chemotherapy for treating postoperative NSCLC patients, but the toxicity and side effects of chemotherapy can decrease quality of life (QOL) of patients. Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival and improve QOL, but high-level evidences are needed.
The investigators perform a randomized, double-blind study in NSCLC patients after complete resection with stage I-III. Patients are randomized over observational group (TCM granules plus chemotherapy), and control group (TCM placebo plus chemotherapy). The investigators will observe 4 treatment periods, after that the observational group will be treated for another 4 months with integrated TCM combined with western medicine treatment (oral TCM medicines plus TCM intravenous injections), and there is no intervene measures in control group. Regular follow-up will be arranged. The primary efficacy assessments are: QOL (QLQ-C30 scales); Secondary efficacy assessments are: (1) 2-year disease-free survival rate; (2) disease-free survival; other efficacy assessments are: (1) TCM symptoms changes; (2) tumor markers (CEA, CA-125 and CYFRA21-1) and so on. Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with Western medicine treatment has a better efficacy on improving QOL of patients, prolonging disease-free survival time than that of chemotherapy treatment. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441752
|Contact: xu firstname.lastname@example.org|
|ShanghaiUTCM||Not yet recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xu Ling 64385700-1313 email@example.com|
|Shanghai, Shanghai, China, 200032|
|Contact: xu ling 64385700-1313 firstname.lastname@example.org|
|Principal Investigator:||xu ling||Shanghai University of Traditional Chinese Medicine|
|Principal Investigator:||xu ling, doctor||Shanghai University of Traditional Chinese Medicine|