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

Metastatic Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01096745
• Other study ID #: GNUHIRB-2010-5
• Status: Terminated
• Phase: Phase 2
• First received: March 30, 2010
• Last updated: June 21, 2011
• Start date: July 2010
• Est. completion date: September 2013

Study information

• Verified date: June 2011
• Source: Gyeongsang National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Locally Advanced Biliary Tract Cancer
• Metastatic Biliary Tract Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang University Hospital	Jinju	Gyeongsang Namdo

Sponsors (4)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital	Chung-Ang University, Dong-A University, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes