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

Phase 2

Completed

• Conditions: Metastatic Biliary Cancer
• Interventions: Drug: Gemcitabine plus Cisplatin; Drug: S-1 plus cisplatin

• Registration Number: NCT01375972
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP treatment	Gemcitabine plus Cisplatin	Gemcitabine plus Cisplatin combination chemotherapy
SP treatment	S-1 plus cisplatin	S-1 plus cisplatin combination chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate at 6 months	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 Outcome Measures

Name	Time	Method
Response rate	6 months	Response to chemotherapy will be assessed using RECIST 1.0 criteria.
Toxicities	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.
overall survival	up to 36 months	Overall survival is calculated from the date of enrollment to the date of death from any cause.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of