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Completed

NCT Number: NCT01375972

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

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.

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Key information

Conditions

Metastatic Biliary Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, 138736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

S-1 plus cisplatin

Drug

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

Gemcitabine plus cisplatin

Drug

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

Primary outcomes

  1. Progression-free survival rate at 6 months

    Time frame: 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.

Secondary outcomes

  1. Response rate

    Time frame: 6 months

    Response to chemotherapy will be assessed using RECIST 1.0 criteria.

  2. Toxicities

    Time frame: Up to 24 months

    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.

  3. overall survival

    Time frame: up to 36 months

    Overall survival is calculated from the date of enrollment to the date of death from any cause.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2011
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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