MedPath

The safety and efficacy of Korean medicine including Rhus vernificlua stokes combined with 1st line chemotherapy for advanced or metastatic pancreatic cancer patients

Not Applicable
Conditions
Neoplasms
Registration Number
KCT0007496
Lead Sponsor
Kyung Hee University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

• 19 years of age or older
• Pancreatic cancer (neoplasm) was confirmed by biopsy
• Who are diagnosed as stage 3 or 4 of TNM staging based on the 8th edition of the AJCC, and are inoperable
• Who are scheduled for combination treatment with 5-FU or gemcitabine-based/mono first palliative chemotherapy and traditional Korean medicine including Rhus verniciflua stokes or within 2 months of starting the treatment
• Whose life expectancy is more than 3 months
• The Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
• Those who understand the research content and agree to participate in the research

Exclusion Criteria

• Pregnant women, lactating women
• Patients with active brain metastases showing clinically significant neurological symptoms or signs
•Those who have clinically significant skeletal related events, including pathological fractures and spinal cord compressions, and require radiotherapy or surgical therapy
•Those who have been diagnosed with other new primary cancers that may affect the patient's condition within the last 5 years
•Who are judged to be inappropriate for the research

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Symptoms and incidence of adverse events based on CTCAE ver 5.0
Secondary Outcome Measures
NameTimeMethod
Progression free survival;Time to metastasis;overall response rate based on RECIST;overall survival;disease related overall survival;Early end rate according to CTCAE grade 3 or higher;EORTC QLQ C30 (quality of life questionnaire);Pattern questionnaire for tradition Korean medicine
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