Clinical trial NCT02346318: The Randomized Controlled Clinical Trial of Kushen Injection
Official title: The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lung Cancer
Keywords: Radiotherapy
Adverse Effect
Dermatitis or Eczema
Lead sponsor: Beijing Zheng Ju Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rates of incidence and the degree of adverse reactions caused by redioterapy
timeFrame: 6 months
Secondary outcomes:
measure: The completion rate of radiotherapy
timeFrame: 2 months
measure: Clinical Symptoms (MDASI-TCM)
timeFrame: 6 months
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 6 months
measure: ECOG PS (ECOG PS score)
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Gene molecule detection (EGFR)
timeFrame: 4 weeks
measure: Pulmonary function tests (FEV1,FVC,DLCO)
timeFrame: 6 months
measure: Immune function (Observation indexes including NK、T lymphocyte subpopulation（CD3、CD4、CD8）、CD4/CD8)
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong cancer hospital
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Shuanghu Yuan, postdoctoral
role: PRINCIPAL_INVESTIGATOR
References: