Clinical trial NCT01780181: Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: lung cancer
traditional Chinese medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Fudan University
First posted: 2013-01-30
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pathologically or cytologically confirmed of stage IIIb-IV NSCLC； Ages Eligible for Study: ≥65 years old; TCM syndromes are deficiency of Yin, deficiency of Qi and deficiency of both Qi and Yin.

Brief summary: The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival（PFS）
timeFrame: 2 months
Secondary outcomes:
measure: overall survival
timeFrame: 2 months
measure: Objective response rate
timeFrame: 2 months
measure: Time-to-Progression(TTP)
timeFrame: 2 months
measure: quality of life(QOL)
timeFrame: one cycle
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhiyi Zhou
state: Shanghai
Study officials:
affiliation: Longhua Hospital
name: Zhiyi Zhou, CMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou ZY, Xu L, Li HG, Tian JH, Jiao LJ, You SF, Han ZF, Jiang Y, Guo HR, Liu H. Chemotherapy in conjunction with traditional Chinese medicine for survival of elderly patients with advanced non-small-cell lung cancer: protocol for a randomized double-blind controlled trial. J Integr Med. 2014 May;12(3):175-81. doi: 10.1016/S2095-4964(14)60028-5.