NCT02346318

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_4 lung-cancer

Timeline
Completed

Started Nov 2014

Typical duration for phase_4 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

December 4, 2014

Last Update Submit

July 20, 2017

Conditions

Lung Cancer

Keywords

RadiotherapyAdverse EffectDermatitis or Eczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • The completion rate of radiotherapy

    2 months

  • Clinical Symptoms (MDASI-TCM)

    6 months

  • Quality of Life (EORTC QLQ-C30)

    6 months

  • ECOG PS (ECOG PS score)

    6 months

  • Weight

    6 months

  • +3 more secondary outcomes

Study Arms (2)

KS injection arm

EXPERIMENTAL

Radiation and chemotherapy and compound Kushen Injection

Drug: Compound Kushen Injection

Control arm

NO INTERVENTION

Radiation and chemotherapy

Interventions

Compound Kushen InjectionDRUG

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

Also known as: KS injection
KS injection arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong cancer hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsDermatitisEczema

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Shuanghu Yuan, postdoctoral

    Shandong Cancer Hospital and Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongsheng Lin, Bachelor

CONTACT

86-10-63200600bjzhengju@126.com

Libo Xiao, Bachelor

CONTACT

86-1381164609513811646095@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

January 27, 2015

Study Start

November 1, 2014

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

July 21, 2017

Record last verified: 2014-10

Locations

CN(1)