NCT02900742

Clinical Study of Chinese Medicine Plus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer

Study of Chinese Medicine Plus Chemotherapy Maintenance Versus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer: A Randomized Double-blind Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators performed a randomized, prospective study method on observation of Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The investigators plan to involve 100 cases for observation in 3 years (50 cases for chemotherapy maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that integrated TCM combined with chemotherapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of chemotherapy maintenance.

Detailed description

Maintenance therapy refers to systemic therapy that may be given for patients with advanced NSCLC after 4 to 6 cycles of first-line chemotherapy. However, patients are only candidates for maintenance therapy if they have responded to their previous treatment or have stable disease and their tumors have not progressed. Pemetrexed, docetaxel and gemcitabine have been approved for chemotherapy maintenance in the NCCN Guide. Chemotherapy maintenance can be partly extend patient's TTP, but the toxicity and the side effects of chemotherapy will decrease the QOL, and even lose the opportunity to receive subsequent therapy. Besides, high cost of chemotherapy will cause greater economic pressure on patients. Our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve QOL, but high-level evidences are needed. The investigators perform a multicenter, randomized, double-blind controlled, prospective study in advanced non small cell lung cancer patients with stage Ⅲ～Ⅳ.Advanced NSCLC patients after first-line chemotherapy will choose maintenance therapy according to the patient's wishes, including targeted therapy maintenance, chemotherapy maintenance and maintenance of TCM therapy. Patients who choose chemotherapy maintenance are randomized over observational group (TCM granules plus chemotherapy maintenance),and control group (TCM placebo plus chemotherapy maintenance). The treatment should be continued until evidence of disease progression or unacceptable toxicity, and after that regular follow-up will be arranged. The primary efficacy assessments are: PFS (progression-free survival）; Secondary efficacy assessments are: (1) OS(overall survival); (2) Objective response rate; (3) TTP（Time-to-Progression）; (4) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0 scales;Lung Cancer Symptom Scale,LCSS); (5)other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time.The investigators expect that integrated TCM combined with chemotherapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of chemotherapy maintenance. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	YiQiFang	Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.
DRUG	YangYinFang	Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.
DRUG	YiQiYangYinFang	Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.
DRUG	Gemcitabine®	"Gemcitabinie®","Gemzar",1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days until progression or unacceptable toxicity develops.
DRUG	Pemetrexed®	"Pemetrexed®","Alimta",500 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity develops.
DRUG	Docetaxel®	"Docetaxel®","Taxotere",75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
DRUG	placebo granules	Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-12-30
• Completion: 2017-06-01
• First posted: 2016-09-14
• Last updated: 2019-04-12