- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346318
The Randomized Controlled Clinical Trial of Kushen Injection
July 20, 2017 updated by: Beijing Zheng Ju Medical Technology Co., Ltd.
The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer
The randomized controlled multicenter clinical study of compound Kushen Injection to reduce the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials,The main purpose is to evaluate the effect of compound Kushen Injection in preventing and reducing the radiotherapy related adverse reactions.
The participants of the clinical trials are patients with lung cancer who need thoracic radiotherapy.
In clinical trials, one group of participants is given compound Kushen Injection with chemoradiotherapy, while another group is only given chemoradiotherapy.
The period of trials is 18 months.
Study Overview
Detailed Description
Patients with lung cancer who need thoracic radiotherapy will be enrolled in the trial, then seprated randomly in two group,the KS injection group treated with chemoradiotherapy plus KS injection; the contral group treated with chemoradiotherapy only.
After 6 months observation, The rates of incidence and the degree of adverse reactions caused by redioterapy; the completion rate of radiotherapy; clinical Symptoms; Qof and pulmonary function tests etc. will be evaluated.
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongsheng Lin, Bachelor
- Phone Number: 86-10-63200600
- Email: bjzhengju@126.com
Study Contact Backup
- Name: Libo Xiao, Bachelor
- Phone Number: 86-13811646095
- Email: 13811646095@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China
- Recruiting
- Shandong Cancer Hospital
-
Contact:
- Shuanghu Yuan, doctor
-
-
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:
- Before the start of the study, All patients have been fully understood the reseach and the must sign the informed consent
- To be aged from 18 to 75 years old, both gender
- The lung cancer diagnosis must be proved by pathology
- According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter more than at least 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm)
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Lung function FEV1 more than at least 1Land more than 50% A normal value
- The function of each organ is basically normal :ANC more than 1.5*10^9/L, Platelet count more than 100*10^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5*ULN, AST (SGOT), ALT (SGPT) less than 2.5*ULN(less than 5*ULN, if with liver metastases), SCr less than 1.5*ULN
- The expected survival tme must more than 6 months.
Exclusion Criteria:
- Lung or mediastinal have received radiotherapy before or ever treated with Compound Kushen Injection within 2weeks
- Pregnancy or lactation women
- Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy - Participating or within the last 30 days participated in other clinical trials
- Hypersensitiveness to any kind of trial regime
- Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence
- Estimating the compliance of patients to participate in this clinical trial is insufficient.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KS injection arm
Radiation and chemotherapy and compound Kushen Injection
|
Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.
Other Names:
|
No Intervention: Control arm
Radiation and chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rates of incidence and the degree of adverse reactions caused by redioterapy
Time Frame: 6 months
|
radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The completion rate of radiotherapy
Time Frame: 2 months
|
Compare two groups of patients with completion of the radiotherapy plans
|
2 months
|
Clinical Symptoms (MDASI-TCM)
Time Frame: 6 months
|
MDASI-TCM
|
6 months
|
Quality of Life (EORTC QLQ-C30)
Time Frame: 6 months
|
EORTC QLQ-C30
|
6 months
|
ECOG PS (ECOG PS score)
Time Frame: 6 months
|
ECOG PS score
|
6 months
|
Weight
Time Frame: 6 months
|
After the treatment,Healing after weight 1 kg to "add",Reduce 1 kg to "fall",Less than 1 kg of change as a "stable"
|
6 months
|
Gene molecule detection (EGFR)
Time Frame: 4 weeks
|
EGFR
|
4 weeks
|
Pulmonary function tests (FEV1,FVC,DLCO)
Time Frame: 6 months
|
FEV1,FVC,DLCO
|
6 months
|
Immune function (Observation indexes including NK、T lymphocyte subpopulation(CD3、CD4、CD8)、CD4/CD8)
Time Frame: 6 months
|
Observation indexes including NK、T lymphocyte subpopulation(CD3、CD4、CD8)、CD4/CD8
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shuanghu Yuan, postdoctoral, Shandong Cancer Hospital and Institute
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
November 1, 2014
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
December 4, 2014
First Submitted That Met QC Criteria
January 26, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 20, 2017
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014EC085-01
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.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on Compound Kushen Injection
-
Zhong WangShanxi Zhendong pharmaceutical Co. LTD.CompletedAdverse Drug Events | Adverse Drug Reactions | Severe Adverse Events | Safety Surveillance | Severe Adverse ReactionsChina
-
Women's Hospital School Of Medicine Zhejiang UniversityNot yet recruiting
-
Guang'anmen Hospital of China Academy of Chinese...RecruitingAdvanced Colorectal CarcinomaChina
-
Berg, LLCCompletedSolid TumorsUnited States
-
Nanjing Yoko Biomedical Co., Ltd.Completed
-
Shanxi Zhendong Pharmacy Co., LtdRecruitingRadiation-induced Oral MucositisChina
-
Peking Union Medical College HospitalUnknownLactate | Severe Sepsis With Septic Shock
-
Nanjing Yoko Biomedical Co., Ltd.SuspendedAcute Ischemic StrokeChina
-
Peking Union Medical College HospitalNot yet recruiting
-
ou tongwenUnknown