Status:
COMPLETED
Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Biliary Tract Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 Seconda...
Detailed Description
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 Secondar...
Eligibility Criteria
Inclusion
- 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 or equal 2.0 mg/dL, and creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockcroft-Gault formula).
- Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
- Patients must agree to have indwelling venous catheter implanted.
- Women or men of reproductive potential should agree to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Exclusion
- Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy.
- Patients with central nervous system metastasis
- Patients with active infection
- Pregnant or breast-nursing women
- Patients with active cardiopulmonary disease or history of ischemic heart disease
- Patients who have peripheral neuropathy \> Grade I of any etiology, presence of grade 2 or above ascites or pleural effusion, or ≥ grade 2 of diarrhea.
- Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
- Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment
- Patients who are under biologic treatment for their malignancy
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03406299
Start Date
April 19 2018
End Date
December 31 2024
Last Update
May 22 2025
Active Locations (1)
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1
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei, Taiwan