NCT01375972

Brief Summary

To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

3.3 years

First QC Date

June 15, 2011

Last Update Submit

December 5, 2011

Conditions

Metastatic Biliary Cancer

Keywords

biliary cancersystemic chemotherapyS-1gemcitabinecisplatin

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate at 6 months

    progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.

    6 months

Secondary Outcomes (3)

  • Response rate

    6 months

  • Toxicities

    Up to 24 months

  • overall survival

    up to 36 months

Study Arms (2)

SP treatment

EXPERIMENTAL

S-1 plus cisplatin combination chemotherapy

Drug: S-1 plus cisplatin

GP treatment

ACTIVE COMPARATOR

Gemcitabine plus Cisplatin combination chemotherapy

Drug: Gemcitabine plus Cisplatin

Interventions

S-1 plus cisplatinDRUG

S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks

SP treatment
Gemcitabine plus CisplatinDRUG

Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks

GP treatment

Eligibility Criteria

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

You may qualify if:

  • Pathologically proven biliary adenocarinoma
  • Age \> 18
  • Evaluable disease
  • ECOG performance status of 2 or better
  • No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
  • Adequate bone marrow function A. WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL B. Hemoglobin \>9.0 g/dL C. Platelets \> 100,000/µL
  • Adequate kidney function (creatinine\<1.5 mg/dL)
  • Adequate liver function (bilirubin\<1.5 mg/dL \[\< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction\], transaminases levels\<3 times the upper normal limit, and serum albumin of \>2.5 mg/dL)
  • No serious medical or psychological condition that would preclude study treatment
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if:

  • Other tumor type than adenocarcinoma
  • Evidence of GI bleeding or GI obstruction
  • Presence or history of CNS metastasis
  • Pregnancy or breastfeeding
  • Other serious illness or medical conditions
  • Axial skeletal radiotherapy within 6 months
  • Neuropathy grade 2 or worse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138736, South Korea

Location

Related Publications (1)

  • Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.

    PMID: 22559158DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

S-1 plus cisplatinGemcitabineCisplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • MJ Kang, MD, MSc

    Asan Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 20, 2011

Study Start

March 1, 2008

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

KR(1)