Age at least 65 years old unresectable locally advanced or metastatic billiary tract carcinoma. Planned treatment with cisplatin and gemcitabine No prior exposure to cisplatin, carboplatin, or oxaliplatin, or if previously received, had been discontinued for at least 6 months Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 Adequate organ function unresectable, metastasis, cholangiocarcinoma, biliary tract cancer, cisplatin, gemcitabine
Conditions
Interventions
25 mg/m2 + NSS 250 mL IV drip in 1 hr + 1000 mg/m2 + in NSS 100 mL IV drip in 30 min
Day1 Day15 every 4 weeks for 8 cycles,25 mg/m2 + NSS 250 mL IV drip in 1 hr + 1000 mg/m2 + in NSS 100 mL IV drip in
Experimental Drug,Active Comparator Drug
Biweekly-CisGem,Standard-CisGem
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Can understand, give consent, and sign the informed consent certified by the research ethics committee before participating in the research project. 2. Age at least 65 years old. 3. Evidence of radiographically confirmed unresectable locally advanced or metastatic biliary tract carcinoma. 4. Planned treatment with cisplatin and gemcitabine. 5. No prior exposure to cisplatin, carboplatin, or oxaliplatin, or if previously received, had been discontinued for at least 6 months. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 7. Adequate organ function including bone marrow within 2 weeks prior to starting treatment. 8. Have intervals from other treatments as follows: Major surgery: at least 4 weeks. Radiation therapy to the chest: at least 4 weeks, and to other areas: at least 2 weeks. 9. Have a life expectancy of at least 12 weeks. 10. If a male volunteer who is not sterilized and has a fertile wife wishes to participate, contraception must be used before joining the research and continuously thereafter. Donating sperm during participation and within 4 months after the last dose of the study drug is not advisable.
Exclusion criteria
Exclusion criteria: 1. Cancer histologies combinded with the following features: squamous cell carcinoma, small cell, neuroendocrine, or sarcomatoid carcinoma. 2. Cardiac and vascular diseases such as acute coronary syndrome within 6 months, symptomatic heart failure (New York Heart Association Class II-IV), clinically significant arrhythmias, or stroke or transient ischemic attack within 6 months. 3. Uncontrollable comorbid conditions such as infections, hypertension, psychiatric disorders, asthma, etc., not limited to the above-mentioned conditions. 4. Active HIV infection, or active hepatitis B or C infection. 5. Presence of untreated brain metastases or treated but with inability to discontinue steroid treatment. 6. History of drug allergies documented in the study. 7. Presence of other malignancies except those treated and in remission for at least 5 years, excluding non-melanoma skin cancer or in-situ disease without evidence of disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic adverse event grade 3, 4 8 cycles from blood chemistry in each cycle, grading by CTCAE v 5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 12 weeks relative dose intensity 8 cycles calculate dose from medical record,Quality of life 8 cycles EQ-5D-5L Thai version | — |
Countries
Thailand
Contacts
Public ContactPakorn Ruedech
Khonkaen university
Outcome results
None listed