The Randomized Controlled Clinical Trial of Kushen Injection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Compound Kushen Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KS injection arm<br>Radiation and chemotherapy and compound Kushen Injection | Drug: Compound Kushen Injection<br>* Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.<br>* Other names: KS injection;|
| No Intervention: Control arm<br>Radiation and chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The completion rate of radiotherapy | Compare two groups of patients with completion of the radiotherapy plans | 2 months | 
| Clinical Symptoms (MDASI-TCM) | MDASI-TCM | 6 months | 
| Quality of Life (EORTC QLQ-C30) | EORTC QLQ-C30 | 6 months | 
| ECOG PS (ECOG PS score) | ECOG PS score | 6 months | 
| 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 | 
| Gene molecule detection (EGFR) | EGFR | 4 weeks | 
| Pulmonary function tests (FEV1,FVC,DLCO) | FEV1,FVC,DLCO | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Adverse Effect, Dermatitis or Eczema