Overview

Study of GEMOX(Gemcitabine/Oxaliplatin) Versus XELOX(Xeloda/Oxaliplatin) in Advanced Biliary Tract Carcinoma

Status:
Unknown status

Trial end date:
2020-12-01

Target enrollment:
0

Participant gender:
All

Summary

The objective of the trial is to compare Progression free survival between GEMOX (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable Biliary tract carcinoma patients.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Samsung Medical Center

Treatments:

Capecitabine
Gemcitabine
Oxaliplatin

Criteria

Inclusion criteria

1. age ≥ 18

2. histologically or cytologically confirmed adenocarcinoma of biliary tract
(intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer.however, ampulla
of vater cancer is excluded)

3. unresectable or metastatic

4. ECOG performance status of 0~2

5. measurable or evaluable lesion per RECIST 1.1 criteria

6. Life expectancy≥12weeks

7. Adequate marrow, hepatic, renal and cardiac functions Serum aspartate transaminase and
serum alanine transaminase≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x
ULN if liver function abnormalities are due to underlying malignancy Total serum
bilirubin ≤ 1.5 x ULN Absolute neutrophil count(ANC) ≥ 1,500/uL Platelets ≥
100,0000/uL Hemoglobin ≥ 8.0 g/dL

8. chemotherapy naïve patient: prior adjuvant chemoradiation or chemotherapy is allowed
if the last date of drug administration is > 6 months from the study entry date

9. provision of a signed written informed consent

Exclusion criteria

1. severe co-morbid illness and/or active infections

2. ampulla of vater cancer is excluded

3. pregnant or lactating women

4. Active CNS metastases not controllable with radiotherapy or corticosteroids
(however,CNS metastases(except for leptomeningeal seeding) are allowed if controlled
by gamma knife surgery or surgery or radiotherapy or steroid)

5. known history of hypersensitivity to study drugs