Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Drug: TCM Drug: Chemotherapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| 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 |
- Progression-free survival（PFS） [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Objective response rate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Time-to-Progression(TTP) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- quality of life(QOL) [ Time Frame: one cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 76 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
TCM plus chemotherapy
TCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang, four packages,twice a day, three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo;
|
Drug: TCM
TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.The herbal treatment is adapted to the syndromes.
Other Names:
Drug: Chemotherapy
treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1，d8 Q3W GEM 1200mg/m2 d1，d8 Q3W
Other Names:
|
|
Placebo plus chemotherapy
TCM Placebo: oral granules,YangYinFang orYiQiFang or YiQiYangYinFang, 10% of the original dose,four packages,twice a day ,three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo;
|
Drug: Chemotherapy
treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1，d8 Q3W GEM 1200mg/m2 d1，d8 Q3W
Other Names:
|
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| Ages Eligible for Study: | 65 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
- Ages Eligible for Study: ≥65 years old;
- Physical status score (ECOG PS) ≤ 2 scores;
- Estimated life expectancy of at least 12 weeks;
- 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;
- Informed consent from the patient.
Exclusion Criteria:
- Patient with other malignant tumor except NSCLC 5 years previous to study entry.
- Patients who have received single-agent chemotherapy treatment；
- Estimated life expectancy less than 12 weeks;
- Serious problem of heart, liver or kidney with severe dysfunction;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
- Participating in other drug trials;
- Who are allergic to the study drug.
Contacts and Locations| Contact: Zhiyi Zhou, CMD, PhD | 8621-64385700-3822 | zhouzhiyi77@yahoo.com.cn |
| China, Shanghai | |
| Zhiyi Zhou | Not yet recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Zhiyi Zhou, CMD, PhD +8613661707859 zhouzhiyi77@yahoo.com.cn | |
| Principal Investigator: Zhiyi Zhou, CMD, PhD | |
| Principal Investigator: | Zhiyi Zhou, CMD, PhD | Longhua Hospital Affiliated to Shanghai University of TCM |
More Information
No publications provided
| Responsible Party: | Zhiyi Zhou, Longhua Hospital, Shanghai University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01780181 History of Changes |
| Other Study ID Numbers: | 12401905700zzy |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 29, 2013 |
| Health Authority: | China: Science and Technology Commission of Shanghai Municipality |
Keywords provided by Shanghai University of Traditional Chinese Medicine:
|
lung cancer traditional Chinese medicine |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013