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Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269162
Recruitment Status : Unknown
Verified September 2017 by lihegen, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
lihegen, Shanghai University of Traditional Chinese Medicine

Study Description
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Brief Summary:
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Jinfukang Koufuye Drug: Docetaxel Drug: Pemetrexed Drug: Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Jinfukang + Chemotherapy Group Drug: Jinfukang Koufuye
30ml per time, tid, po (d6-21, q21)

Drug: Docetaxel
75mg/m2,ivgtt 30mins, d1

Drug: Pemetrexed
500mg/m2, ivgtt 30mins, d1

Drug: Cisplatin
75mg/m2, ivgtt >2h, d1
Placebo Comparator: Chemotherapy Group Drug: Docetaxel
75mg/m2,ivgtt 30mins, d1

Drug: Pemetrexed
500mg/m2, ivgtt 30mins, d1

Drug: Cisplatin
75mg/m2, ivgtt >2h, d1


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival Rate [ Time Frame: 2 years ]
    From the very beginning of the randomization to the end point when disease relapse or death because of any reason


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
  2. Accept chemotherapy for the first time 6 weeks after operation
  3. Age of 18-75 years old
  4. Eastern Cooperative Oncology Group-PS≤2
  5. N>1.5×109/L、PLT> 100 × 109/L、Hb>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
  6. Voluntary participation in the prospective study with signed informed consent

Exclusion Criteria:

  1. No pathology-confirmed diagnosis patients
  2. Patients with overall survival time<6 months
  3. Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
  4. Pregnant or breast feeding patients
  5. Patients with uncontrollable mentally disease
  6. Patients with diabetes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269162


Sponsors and Collaborators
lihegen
Investigators
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Principal Investigator: Hegen Li Longhua Hospital
More Information
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Responsible Party: lihegen, Director of Oncology Department Longhua Hospital, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03269162    
Other Study ID Numbers: SHDC12016114
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors