Study of Chinese Medicine Plus Chemotherapy Maintenance Versus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer: A Randomized Double-blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 主要终点
- Overall survival(OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed of stage IIIa-IV NSCLC;
- •The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
- •At the age of 18 -75 years old;
- •Physical status score (ECOG PS) ≤ 2 scores;
- •Estimated life expectancy of at least 12 weeks;
- •Participants have no major organ dysfunction: hemoglobin ≥10 g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
- •Planning for chemotherapy maintenance.
- •Informed consent from the patient.
排除标准
- •The efficacy evaluation of the first-line therapy is progressive disease;
- •Patient with other malignant tumor except NSCLC 5 years previous to study entry;
- •Patient already receiving targeted therapy or other anticancer treatment;
- •Allergic to chemotherapy drugs;
- •Estimated life expectancy less than 12 weeks;
- •History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
- •Pregnant or child breast feeding women;
- •Mental or cognitive disorders.
研究组 & 干预措施
TCM granules plus Chemotherapy
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: YiQiFang (Drug)
TCM granules plus Chemotherapy
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: YangYinFang (Drug)
TCM granules plus Chemotherapy
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: YiQiYangYinFang (Drug)
TCM granules plus Chemotherapy
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: Gemcitabine® (Drug)
TCM granules plus Chemotherapy
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: Pemetrexed® (Drug)
TCM granules plus Chemotherapy
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: Docetaxel® (Drug)
Placebo granules plus Chemotherapy
Placebo granules: oral granules, oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: Gemcitabine® (Drug)
Placebo granules plus Chemotherapy
Placebo granules: oral granules, oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: Pemetrexed® (Drug)
Placebo granules plus Chemotherapy
Placebo granules: oral granules, oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: Docetaxel® (Drug)
Placebo granules plus Chemotherapy
Placebo granules: oral granules, oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
干预措施: placebo granules (Drug)
结局指标
主要结局
Overall survival(OS)
时间窗: 2 months
It referred to the interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up.
次要结局
- Quality of life (QOL)(2 months)
- Quality of life(QOL)(2 months)
- Progression-free survival(PFS)(2 months)
- Overall response rate(ORR)(2 months)
研究者
Ling Xu
Principal Investigator
Shanghai University of Traditional Chinese Medicine