Lung CancerPhase 4NCT02346318
The Randomized Controlled Clinical Trial of Kushen Injection
A Phase 4 study testing Compound Kushen Injection in people with Lung Cancer, run by Beijing Zheng Ju Medical Technology Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Compound Kushen Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong cancer hospital
Jinan, Shandong
Shuanghu Yuan, doctor
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Compound Kushen Injection
- Keywords
- Radiotherapy, Adverse Effect, Dermatitis or Eczema
- Medical subject headings
- Lung Neoplasms, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Kushen InjectionDrug
Also called KS injection
Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.
| Study group | Role | What they receive |
|---|---|---|
| KS injection arm | Experimental | Radiation and chemotherapy and compound Kushen Injection Receives: Drug: Compound Kushen Injection |
| Control arm | No intervention | Radiation and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of incidence and the degree of adverse reactions caused by redioterapy
radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease
Measured: 6 months
Secondary outcomes (8)
The completion rate of radiotherapy
Compare two groups of patients with completion of the radiotherapy plans
Measured: 2 months
Clinical Symptoms (MDASI-TCM)
MDASI-TCM
Measured: 6 months
Quality of Life (EORTC QLQ-C30)
EORTC QLQ-C30
Measured: 6 months
ECOG PS (ECOG PS score)
ECOG PS score
Measured: 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"
Measured: 6 months
Gene molecule detection (EGFR)
EGFR
Measured: 4 weeks
Pulmonary function tests (FEV1,FVC,DLCO)
FEV1,FVC,DLCO
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zheng Ju Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuanghu Yuan, postdoctoral, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346318
- Sponsor's protocol ID
- 2014EC085-01
- Status last verified
- Oct 2014
- First submitted
- 4 Dec 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer
- ClinicalTrials.gov ID
- NCT02346318
- Acronym / sponsor ID
- 2014EC085-01
- Conditions
- Lung Cancer
- Keywords
- Radiotherapy, Adverse Effect, Dermatitis or Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Zheng Ju Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KS injection arm | Experimental | Drug: Compound Kushen InjectionRadiation and chemotherapy and compound Kushen Injection |
| Control arm | No intervention | –Radiation and chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Kushen InjectionAlso: KS injectionCompound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml. | Drug | KS injection arm |
Primary outcome
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
8 secondary outcomes
The completion rate of radiotherapy
Time frame: 2 months
Clinical Symptoms (MDASI-TCM)
Time frame: 6 months
Quality of Life (EORTC QLQ-C30)
Time frame: 6 months
ECOG PS (ECOG PS score)
Time frame: 6 months
Weight
Time frame: 6 months
Gene molecule detection (EGFR)
Time frame: 4 weeks
Pulmonary function tests (FEV1,FVC,DLCO)
Time frame: 6 months
Immune function (Observation indexes including NK、T lymphocyte subpopulation（CD3、CD4、CD8）、CD4/CD8)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuanghu Yuan, postdoctoral principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Kushen Injection in people with Lung Cancer, run by Beijing Zheng Ju Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongsheng Lin, Bachelor (86-10-63200600, bjzhengju@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rates of incidence and the degree of adverse reactions caused by redioterapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.