Cholangiocarcinoma patients after curative resection Cholangiocarcinoma
Conditions
Interventions
Gemcitabine plus cisplatin group will be started to receive 8 cycles of such drug at Day1 and Day8, every 3 weeks, administered by beginning with cisplatin 25 mg per square meter of body-surface area,
Experimental Drug,Active Comparator Drug
Gemcitabine (Gemzar®) plus Cisplatin (Platinol®),Gemcitabine (Gemzar®) alone
Sponsors
Faculty of Medicine, Khon Kaen University
Cholangiocarcinoma Screening and Care Program (CASCAP)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients age 18 -75 years. Patients who had been detected pathological proven cholangiocarcinoma CCA and achieved curative resection. Patients who had been received full staging by CT chest with whole abdomen before entry into the study. Patients who had undergone either R0 or R1 resection within 4-12 weeks prior to chemotherapy. Patients who had never been treated with radiation and chemotherapy before surgery. Patients who have either 0 or 1 scale of performance status assessed by Eastern Cooperative Oncology Group. Patients who willingness to be followed the treatment for at least three years after being treated with surgery. 10. Female patients who can get pregnancy and a male patient who has a partner that can get pregnancy willingness to comply with a highly effective method of contraception i.e. Take a pill, injectable, ring or reversible during start screening and failure rate 90 days(3 months) continue using it after the last drug administration. Patients with premature Females patients who are pregnant or during menopause period (Menopause is defined as occurring 12 months after your last menstrual period that are not cause by possible others) before received screen or received vasectomy more than 1 months and/or total hysterectomy. Females patients who are pregnant (reproductive age) have negative pregnancy test before entry into study, that should be get pregnancy willingness to comply with a highly effective method of contraception i.e. Take a pill, injectable, ring or reversible during start screening and continue using it more than 28 days after the last drug administration.
Exclusion criteria
Exclusion criteria: 1. Presentation of CCA metastases to any organ excluding the regional lymph node. 2. Patients with any serious infection within 4 weeks prior to randomization yet not limit to those who have been admitted in hospital due to sepsis or severe pneumonia. 3. Patients known to be allergic to gemcitabine or cisplatin. 4. Patients know to be allergic to seafood and contrast materials for Computed Tomography CT scan or Magnetic Resonance Imaging MRI scan. 5. Patient who unable to understand the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire EORTC-QLQ-C30 which had been translated to local language. 6. Patients found to have cancers history with in 5 years except carcinoma in situ of endometrial tissue or basal cell skin cancer which were treated properly. 7. Patients who are pregnant or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival 3 years Measures the length of time that a patient is both alive and dead or lost to follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival 3 years Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1,Complication/ Side effect/ Adverse Event/ Serious Adverse Event 3 years Common Terminology Criteria for Adverse Events (NCI CTCAE v 4.0),Quality of Life 3 year European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version3.0,Health Status 3 years EuroQol five dimensions questionnaire (EQ-5D-3L) | — |
Countries
Thailand
Contacts
Public ContactAumkhae Sookprasert
Faculty of Department of Medicine Khon Kaen University, Thailand
Outcome results
None listed