Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

April 19, 2018

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Biliary Tract Neoplasms
Interventions
DRUG

Tegafur

Tegafur(S-1) 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day)

DRUG

Leucovorin

Leucovorin 30 mg/b.i.d., day 1-7

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1

DRUG

Gemcitabine

"Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate (, 10 mg/m2/min) infusion, day 1; After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin. in SLOG arm.~Gemcitabine 1000 mg/m2 in 100 mL of normal saline, IV drip for 30 mins on D1 and D8 ,in GC arm"

DRUG

Cisplatin

Cisplatin 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8

Trial Locations (1)

Unknown

Taiwan Cooperative Oncology Group, National Health Research Institutes, Taipei

All Listed Sponsors
lead

National Health Research Institutes, Taiwan

OTHER

NCT03406299 - Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer | Biotech Hunter | Biotech Hunter