The Randomized Controlled Clinical Trial of Kushen Injection

Lung Cancer Clinical Trial

Official title:

The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346318
• Other study ID #: 2014EC085-01
• Status: Recruiting
• Phase: Phase 4
• First received: December 4, 2014
• Last updated: July 20, 2017
• Start date: November 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2014
• Source: Beijing Zheng Ju Medical Technology Co., Ltd.
• Contact: Hongsheng Lin, Bachelor
• Phone: 86-10-63200600
• Email: bjzhengju[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Compound Kushen Injection
Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.

Locations

Country	Name	City	State
China	Shandong cancer hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zheng Ju Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rates of incidence and the degree of adverse reactions caused by redioterapy	radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease	6 months
Secondary	The completion rate of radiotherapy	Compare two groups of patients with completion of the radiotherapy plans	2 months
Secondary	Clinical Symptoms (MDASI-TCM)	MDASI-TCM	6 months
Secondary	Quality of Life (EORTC QLQ-C30)	EORTC QLQ-C30	6 months
Secondary	ECOG PS (ECOG PS score)	ECOG PS score	6 months
Secondary	Weight	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
Secondary	Gene molecule detection (EGFR)	EGFR	4 weeks
Secondary	Pulmonary function tests (FEV1,FVC,DLCO)	FEV1,FVC,DLCO	6 months
Secondary	Immune function (Observation indexes including NK?T lymphocyte subpopulation(CD3?CD4?CD8)?CD4/CD8)	Observation indexes including NK?T lymphocyte subpopulation(CD3?CD4?CD8)?CD4/CD8	6 months