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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03269162
• Other study ID #: SHDC12016114
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 18, 2017
• Last updated: September 13, 2017
• Start date: September 30, 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2017
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Jinfukang Koufuye
30ml per time, tid, po (d6-21, q21)
• Docetaxel
75mg/m2,ivgtt 30mins, d1
• Pemetrexed
500mg/m2, ivgtt 30mins, d1
• Cisplatin
75mg/m2, ivgtt >2h, d1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
lihegen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival Rate	From the very beginning of the randomization to the end point when disease relapse or death because of any reason	2 years