NCT01470443

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 28, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

4.9 years

First QC Date

November 9, 2011

Last Update Submit

May 17, 2019

Conditions

Biliary Tract (Intrahepatic, Extrahepatic Cholangiocarcinoma, Gall Bladder) Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival of GEMOX vs XELOX

    reference 6 months PFS 50% (GEMOX arm), noninferiority 6 months PFS 35% (XELOX arm), 1:1 randomization, accrual 24 months, 6 months follow-up after the last patient registry.

    6 months PFS

Secondary Outcomes (1)

  • Safety profile

    6 months follow-up after the last patient registry.

Study Arms (2)

GEMOX

ACTIVE COMPARATOR

* Gemcitabine 1,000 mg/㎡, day 1 and 8, every 3 weeks * Oxaliplatin 100 mg/㎡, day 1, every 3 weeks

Drug: Oxaliplatin

XELOX

EXPERIMENTAL

Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks Oxaliplatin 130mg/㎡, day 1, every 3 weeks

Drug: Oxaliplatin

Interventions

OxaliplatinDRUG

Oxaliplatin 130mg/㎡, day 1, every 3 weeks

XELOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18
  • histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer.however, ampulla of vater cancer is excluded)
  • unresectable or metastatic
  • ECOG performance status of 0\~2
  • measurable or evaluable lesion per RECIST 1.1 criteria
  • Life expectancy≥12weeks
  • 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
  • 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
  • provision of a signed written informed consent

You may not qualify if:

  • severe co-morbid illness and/or active infections
  • ampulla of vater cancer is excluded
  • pregnant or lactating women
  • 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)
  • known history of hypersensitivity to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical Center

Seoul, 135-710, South Korea

Location

Related Publications (2)

  • Chen R, Zhang Y, Lin K, Huang D, You M, Lai Y, Wang J, Hu Y, Li N. Cost-Effectiveness Analysis of Capecitabine Plus Oxaliplatin Versus Gemcitabine Plus Oxaliplatin as First-Line Therapy for Advanced Biliary Tract Cancers. Front Pharmacol. 2022 Jul 22;13:871262. doi: 10.3389/fphar.2022.871262. eCollection 2022.

    PMID: 35935821DERIVED

  • Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. doi: 10.1093/annonc/mdz058.

    PMID: 30785198DERIVED

MeSH Terms

Conditions

CholangiocarcinomaNeoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

December 28, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2020

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

KR(1)