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Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01375972
First received: June 15, 2011
Last updated: December 5, 2011
Last verified: December 2011

June 15, 2011
December 5, 2011
March 2008
July 2011   (final data collection date for primary outcome measure)
Progression-free survival rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01375972 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Response to chemotherapy will be assessed using RECIST 1.0 criteria.
  • Toxicities [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described.
  • overall survival [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    Overall survival is calculated from the date of enrollment to the date of death from any cause.
Same as current
Not Provided
Not Provided
 
Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma
Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Biliary Cancer
  • Drug: S-1 plus cisplatin
    S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
  • Drug: Gemcitabine plus Cisplatin
    Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
  • Experimental: SP treatment
    S-1 plus cisplatin combination chemotherapy
    Intervention: Drug: S-1 plus cisplatin
  • Active Comparator: GP treatment
    Gemcitabine plus Cisplatin combination chemotherapy
    Intervention: Drug: Gemcitabine plus Cisplatin
Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park do H, 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. PubMed PMID: 22559158.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
August 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pathologically proven biliary adenocarinoma
  2. Age > 18
  3. Evaluable disease
  4. ECOG performance status of 2 or better
  5. No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
  6. 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
  7. Adequate kidney function (creatinine<1.5 mg/dL)
  8. 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)
  9. No serious medical or psychological condition that would preclude study treatment
  10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

  1. Other tumor type than adenocarcinoma
  2. Evidence of GI bleeding or GI obstruction
  3. Presence or history of CNS metastasis
  4. Pregnancy or breastfeeding
  5. Other serious illness or medical conditions
  6. Axial skeletal radiotherapy within 6 months
  7. Neuropathy grade 2 or worse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01375972
AMC_0803
No
JLee, Asan Medical Center
Asan Medical Center
Not Provided
Study Director: MJ Kang, MD, MSc Asan Medical Center
Asan Medical Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP