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Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients

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ClinicalTrials.gov Identifier: NCT01441752
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
xuling, Shanghai University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE September 28, 2011
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
quality of life(QoL) [ Time Frame: every three weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
two-year disease-free survival rate and disease-free survival [ Time Frame: once every three months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients
Official Title  ICMJE State Administration of Traditional Chinese Medicine of Shanghai
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) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with chemotherapy compared to that by chemotherapy alone.
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 35% of postoperative lung cancer patients with stage I died in 5 years due to recurrence or metastasis; the 5-year survival rates of stage II, IIIa, IIIb were 31%, 17.9% and 11.7% respectively. The survival rate was improved by 5% with adjuvant chemotherapy after resection, so regimen consist of platinum-based two chemical medicines are commended as the adjuvant chemotherapy for treating postoperative NSCLC patients, but the toxicity and side effects of chemotherapy can decrease quality of life (QOL) of patients. Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival and improve QOL, but high-level evidences are needed.

The investigators perform a randomized, double-blind study in NSCLC patients after complete resection with stage I-III. Patients are randomized over observational group (TCM granules plus chemotherapy), and control group (TCM placebo plus chemotherapy). The investigators will observe 4 treatment periods, after that the observational group will be treated for another 4 months with integrated TCM combined with western medicine treatment (oral TCM medicines plus TCM intravenous injections), and there is no intervene measures in control group. Regular follow-up will be arranged. The primary efficacy assessments are: QOL (QLQ-C30 scales); Secondary efficacy assessments are: (1) 2-year disease-free survival rate; (2) disease-free survival; other efficacy assessments are: (1) TCM symptoms changes; (2) tumor markers (CEA, CA-125 and CYFRA21-1) and so on. Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with Western medicine treatment has a better efficacy on improving QOL of patients, prolonging disease-free survival time than that of chemotherapy treatment. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: TCM
    three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
    Other Name: Prescriptions from Professor Liu Jiaxiang
  • Drug: placebo
    three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe,with the same color, smell ,taste weight and package
Study Arms  ICMJE
  • Experimental: Chemotherapy + TCM group

    The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.

    Prescriptions formulated into granules origin from Professor Liu Jiaxiang 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 . Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.

    Intervention: Drug: TCM
  • Placebo Comparator: Chemotherapy + placebo group
    The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.we compromise the raw materials for the placebo including 10% of Chinese medicine, food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
349
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2011)
600
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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;
  2. Age > 18 years old;
  3. TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney;
  4. Physical status score (ECOG PS) ≤ 2 scores;
  5. Stage Ib ~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size > 2cm of stage Ia;
  6. Blood routine: N > 1.5×109/L、PLT > 100×109/L, normal liver function and kidney function;
  7. Voluntarily involved to clinical study and sign informed consent.

Exclusion Criteria:

  1. Suffering from other primary malignant tumor in 5 years;
  2. Incomplete resection or uncertain to take resection;
  3. Serious disease of heart, liver, kidney with severe dysfunction;
  4. Pregnancy or breast-feeding women;
  5. Mental or cognitive disorders which would influence judgment of QOL in this study;
  6. During or had adjuvant chemotherapy;
  7. Being participating other drug trials;
  8. Allergy to the drug in our study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01441752
Other Study ID Numbers  ICMJE LC 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party xuling, Shanghai University of Traditional Chinese Medicine
Study Sponsor  ICMJE xuling
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: xu ling Shanghai University of Traditional Chinese Medicine
Principal Investigator: xu ling, doctor Shanghai University of Traditional Chinese Medicine
PRS Account Shanghai University of Traditional Chinese Medicine
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP