Status:
COMPLETED
Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients
Lead Sponsor:
xuling
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The investigators performed a multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL...
Detailed Description
At present the high rate of recurrence and metastasis of postoperative non-small cell lung cancer (NSCLC) patients is one of the leading causes resulting in failure of treating lung cancer. More than ...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma) patients;
- Age \> 18 years old;
- TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney;
- Physical status score (ECOG PS) ≤ 2 scores;
- Stage Ib \~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size \> 2cm of stage Ia;
- Blood routine: N \> 1.5×109/L、PLT \> 100×109/L, normal liver function and kidney function;
- Voluntarily involved to clinical study and sign informed consent.
Exclusion
- Suffering from other primary malignant tumor in 5 years;
- Incomplete resection or uncertain to take resection;
- Serious disease of heart, liver, kidney with severe dysfunction;
- Pregnancy or breast-feeding women;
- Mental or cognitive disorders which would influence judgment of QOL in this study;
- During or had adjuvant chemotherapy;
- Being participating other drug trials;
- Allergy to the drug in our study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT01441752
Start Date
November 1 2011
End Date
March 1 2015
Last Update
June 27 2016
Active Locations (2)
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1
ShanghaiUTCM
Shanghai, Shanghai Municipality, China, 200032
2
Xuling
Shanghai, Shanghai Municipality, China, 200032