The Randomized Controlled Clinical Trial of Kushen Injection

Beijing Zheng Ju Medical Technology

Status and phase

Unknown

Phase 4

Conditions

Lung Cancer

Treatments

Drug: Compound Kushen Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02346318

2014EC085-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.