| Study name |
A randomised controlled trial of gemcitabine alone versus gemcitabine plus cisplatin as an adjuvant chemotherapy after curative intent resection of cholangiocarcinoma (GeCiCCA) |
| Methods |
Multicentre, prospective, randomised controlled phase III trial |
| Participants |
People with the following:
age 18 to 75 years detected pathological‐proven cholangiocarcinoma and achieved curative resection received full staging by CT chest with whole abdomen before entry into the study undergone either R0 or R1 resection within 4 to 12 weeks prior to chemotherapy not treated with radiation and chemotherapy before surgery ECOG performance status 0 to 1 -
blood examinations with the following results:
cell blood count ( neutrophils > 1.5 x 10^9/ L , platelet > 100 x 10^9 /L, haemoglobin > 8.0 g/dL. Patients may be receiving blood transfusion or erythropoiesis stimulating agent to meet the criteria. liver function: concentrations of enzymes AST and ALT in the blood 3 times ULN along with that of ALP 5 times ULN kidney function: creatinine clearance equals 50 millilitres per minute or greater by Cockcroft‐Gault
willingness to be followed the treatment for at least 3 years after surgery females of childbearing potential and males with partner of childbearing potential willingness to comply with a highly effective method of contraception, i.e. 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 11.1:
female patients who pregnant or during menopause period (menopause is defined as occurring 12 months after last menstrual period unrelated to other possible causes) before received screen or received vasectomy more than 1 month and/or total hysterectomy female 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. pill, injectable, ring or reversible during start screening and continue using it more than 28 days after the last drug administration
|
| Interventions |
Group I: gemcitabine plus cisplatin
Group II: gemcitabine |
| Outcomes |
Primary outcome:
Secondary outcome:
|
| Starting date |
16 November 2016 |
| Contact information |
Wilaiphorn Thinkhamrop; w.think@gmail.com |
| Notes |
Expected completion date: 16 November 2022 |
