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

September 13, 2017 updated by: lihegen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

lihegen

Investigators

  • Principal Investigator: Hegen Li, Longhua Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2016

Primary Completion (ANTICIPATED)

September 30, 2019

Study Completion (ANTICIPATED)

September 30, 2019

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (ACTUAL)

August 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC12016114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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