Clinical trial NCT02900742: Clinical Study of Chinese Medicine Plus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer
Official title: Study of Chinese Medicine Plus Chemotherapy Maintenance Versus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer: A Randomized Double-blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: lung cancer
traditional Chinese medicine
maintenance therapy
chemotherapy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2016-09-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Pathologically or cytologically confirmed of stage IIIa-IV NSCLC;
2. The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
3. At the age of 18 -75 years old;
4. Physical status score (ECOG PS) ≤ 2 scores;
5. Estimated life expectancy of at least 12 weeks;
6. 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;
7. Planning for chemotherapy maintenance.
8. Informed consent from the patient.

Exclusion Criteria:

1. The efficacy evaluation of the first-line therapy is progressive disease;
2. Patient with other malignant tumor except NSCLC 5 years previous to study entry;
3. Patient already receiving targeted therapy or other anticancer treatment;
4. Allergic to chemotherapy drugs;
5. Estimated life expectancy less than 12 weeks;
6. 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;
7. Pregnant or child breast feeding women;
8. Mental or cognitive disorders.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 2 months
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 2 months
measure: Overall response rate(ORR)
timeFrame: 2 months
measure: Quality of life (QOL)
timeFrame: 2 months
measure: Quality of life(QOL)
timeFrame: 2 months
Other outcomes:
measure: TCM symptoms changes
timeFrame: 2 months
measure: Safety assessment evaluated according to Common Toxicity Criteria
timeFrame: 2 months
Locations:
Study officials:
affiliation: Longhua Hospital Affiliated to Shanghai University
name: Ling Xu, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Q, Jiao L, Wang S, Chen P, Bi L, Zhou D, Yao J, Li J, Chen Z, Jia Y, Zhang Z, Shen W, Zhu W, Xu J, Gao Y, Gong Y, Xu L. Maintenance Chemotherapy With Chinese Herb Medicine Formulas vs. With Placebo in Patients With Advanced Non-small Cell Lung Cancer After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind Trial. Front Pharmacol. 2018 Nov 6;9:1233. doi: 10.3389/fphar.2018.01233. eCollection 2018.