The effect of concomitant administration of gemcitabine plus cistplatin and Bojungikgi-tang for improving quality of life and reducing adverse event in metastatic and progressive bile duct carcinoma
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001884
- Lead Sponsor
- Daegu Catholic University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1) Diagnosed as metastatic and progressing cholangiocarcinoma of non surgical resection cases, or the caese of incompletly resection worthy of on going checked by CT scans by gemcitabine with cisplatin therapy after 3, 6 or 9 periods of anticancer theparies.
2) Below ECOG performance(Eastern Cooperative Oncology Group) 2
3) Age above 20 and less than 80
4) No cognition deficit
5) Spontaneously agree to join, and sign to the consent form by him or herself of guardians
6) Can be observed during trial periods.
1) Cholangiocarcinoma patients scheduled to be operated after anticancer therapies
2) Need to be surgically operated due to gastrointestinal obstruction
3) Hypertension not controlled by medicins
4) Above 3.4 mg% of serum creatinine
5) allergic or sensitive to Bojungikgi-tang
6) No agreement to the consent form
7) In pregnant or breast feeding state, or expecting a baby during the trial periods.
8) Taking another clinical trial medicines whithin one month
9) Except above cases, the cases of not going on judged by PI or the person in charge
10) No agreement to this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EORTC QLQ-C30,Pain rating scale,weight gain, analgesics,megesterol acetate,Anti-emetics
- Secondary Outcome Measures
Name Time Method CI CTCAE: Hematologic (CBC), GI toxicity(vomiting), renal toxicity (BUN/cr), LFT,RECIST and WHO Criteria(PD,SD,PR)