Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer
65 Years
80 Years
Both
Cancer
Trial Information
Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer
diagnoses and more than 75% of the patients are diagnosed with an advanced stage. ASCO
guidelines recommended that elderly patients with advanced NSCLC use single-agent
chemotherapy. Nearly a decade of clinical trials showed that:the median survival time (MST)
of Vinorelbine is 5-10months,1-year survival rate is 32%;the MST of Gemcitabine is
6.8-9months,the MST of Taxol is 6.8-10.3months.Research had shown that TCM can prolong
long-term survival and improve QOL, but high-level evidence is desperately needed to support
this finding.
The investigators perform a multi-center, randomized, double-blind controlled, prospective
study in elderly patients with advanced NSCLC. Patients are randomized over observational
group (TCM granules plus single-agent chemotherapy), and control group (TCM placebo plus
single-agent chemotherapy). The investigators will observe 4 cycles and after that regular
follow-up will be arranged. The primary end point is: PFS (progression-free survival); the
secondary end points are: (1) OS(overall survival); (2) Objective response rate; (3)
TTP(Time-to-Progression); (4) QOL (EORTC QLQ-L43, TCM syndrome score); (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 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.
Inclusion Criteria:
1. Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
2. Ages Eligible for Study: ≥65 years old;
3. Physical status score (ECOG PS) ≤ 2 scores;
4. Estimated life expectancy of at least 12 weeks;
5. Participants have no major organ dysfunction and chemotherapy contraindications:
hemoglobin ≥9g/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;
6. Informed consent from the patient.
Exclusion Criteria:
1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.
2. Patients who have received single-agent chemotherapy treatment；
3. Estimated life expectancy less than 12 weeks;
4. Serious problem of heart, liver or kidney with severe dysfunction;
5. Pregnant or child breast feeding women;
6. Mental or cognitive disorders;
7. Participating in other drug trials;
8. Who are allergic to the study drug.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Progression-free survival（PFS）
Outcome Time Frame:
2 months
Safety Issue:
Yes
Principal Investigator
Zhiyi Zhou, CMD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Longhua Hospital Affiliated to Shanghai University of TCM
Authority:
China: Science and Technology Commission of Shanghai Municipality
Study ID:
12401905700zzy
NCT ID:
NCT01780181
Start Date:
July 2013
Completion Date:
September 2015
Related Keywords:
- Cancer
- lung cancer
- traditional Chinese medicine
- Lung Neoplasms
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