Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

NCT01096745 | Terminated Phase 2

• 1 other identifier: GNUHIRB-2010-5
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

Conditions

Metastatic Biliary Tract Cancer; Locally Advanced Biliary Tract Cancer

Keywords

Gemcitabine; Cisplatin; S-1; bile duct cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

  From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan

Secondary Outcomes (1)

• Response rate Overall survival Safety profile

  Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan

Study Arms (2)

Gemcitabine/Cisplatin

EXPERIMENTAL

Drug: Gemcitabine, Cisplatin

S-1/Cisplatin

EXPERIMENTAL

D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks

Drug: S-1, Cisplatin

Interventions

Gemcitabine, Cisplatin DRUG

D1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks

Also known as: Gemcitabine - Gemcitane, Cisplatin - Cispulan

Gemcitabine/Cisplatin

S-1, Cisplatin DRUG

D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks

Also known as: S-1; TS-1, Cisplatin ; Cispulan

S-1/Cisplatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age : older than 20
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
• Histologically confirmed adenocarcinoma of the biliary tract
• Metastatic or unresectable biliary cancer
• No prior chemotherapy for biliary cancer
• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
• Adequate bone marrow, liver, renal function

You may not qualify if:

• A patient with no measurable disease
• A patient who received previous palliative chemotherapy for biliary cancer
• A patient who received adjuvant chemotherapy for biliary cancer within 1year
• A patient with previous active or passive immunotherapy.
• A pregnant or lactating patient

Sponsors & Collaborators

• Gyeongsang National University Hospital: lead
• Samsung Medical Center: collaborator
• Dong-A University: collaborator
• Chung-Ang University: collaborator

Study Sites (1)

Gyeongsang University Hospital

Jinju, Gyeongsangnam-do, 660-702, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Bile Duct Neoplasms

Interventions

Gemcitabine; Cisplatin; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hyuk-Chan Kwon, M.D.

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Jung Hun Kang, M.D.

  Gyeongsang University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

KR (1)