Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer (NCT03406299) | Clinical Trial Compass
CompletedPhase 2
Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer
Taiwan92 participantsStarted 2018-04-19
Plain-language summary
To evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving SLOG or GC treatment, Primary objective: 6-month progression-free survival rate
Secondary objectives:
Objective response rate Disease control rate (Objective response rate (ORR) + stable disease ≧ 12 weeks) Progression-free Survival Overall survival Safety profile Biomarker study
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed, advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, hilum bile duct, extrahepatic bile duct and gallbladder), except ampulla vater cancer or combined hepatocholangiocarcinoma.
* presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be≥15 mm in the short axis.
* Patients must have no history of prior chemotherapy for Biliary Tract Cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
* Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
* Patients' baseline Eastern Cooperative Oncology Group (ECOG)performance status must be less than or equal 1.
* Patients' life expectancy must be 12 weeks or greater.
* Patients' age must be more than or equal 20 years old.
* Patients must have adequate bone marrow function, defined as white blood cell (WBC) count ≥3,500/ul, absolute neutrophil count (ANC) 1,500/ul, and platelet count ≥100,000/ul.
* Patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (ALT) 3 times upper normal limit, serum total bilirubin level less than o…
What they're measuring
1
6-month progression-free survival rate
Timeframe: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .
Trial details
NCT IDNCT03406299
SponsorNational Health Research Institutes, Taiwan