the"Fuzheng" Therapy of TCM to Improve the Survival Quali... | NCT02603003

Studies
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs

NCT02603003

Sponsor

Shanghai University of Traditional Chinese Medicine

Status

Completed

Last Update Posted

Sep 20, 2019Actual

Enrollment

218Actual

Phase

Phase 1

Conditions

Non-small Cell Lung Cancer(NSCLC)

Interventions

JinFuKang
Cisplatin
Pemetrexed

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TJH20151021	Registry Identifier	TIAN Jianhui
LB20151106	Registry Identifier	Robin

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Oct 21, 2015

First Submission Date that Met QC Criteria

Nov 10, 2015

First Posted Date

Nov 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2019

Last Update Posted Date

Sep 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

jianhuitian, Clinical Professor, Shanghai University of Traditional Chinese MedicinePrincipal Investigator

Lead Sponsor

Shanghai University of Traditional Chinese MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Detailed Description

Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

218Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cisplatin	Placebo Comparator	Cisplatin	Drug: Cisplatin
Pemetrexed	Placebo Comparator	Pemetrexed	Drug: Pemetrexed
Jinfukang	Experimental	Jinfukang	Drug: JinFuKang Drug: Cisplatin Drug: Pemetrexed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JinFuKang	Drug	po.tid.30ml	Jinfukang	Jin Fukang oral liquid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival	It is decided by a doctor via the clinical examinations	The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.

Secondary Outcomes

Measure	Description	Time Frame
Circulating Tumor Cell	It is decided by a doctor via the clinical examinations	24months
Overall survival	It is decided by a doctor via the clinical examinations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
Patients receiving chemotherapy for the first time in 6 weeks after surgery;
Age from 18 Years to 70 Years;
The liver and renal function were normal,and no other disease.
Patients compliance is good ang can understand the situation of this study and signed informed consent

Exclusion Criteria:

Patients without clear pathological diagnosis;
The expected survival period is morn than 6 months;
Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
Patients with pregnancy or lactation;
Persons with a history of less control.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C544151	jinfukang
D002945	Cisplatin
D000077235	Vinorelbine
D000068437	Pemetrexed
D007267	Injections

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided