Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396668
• Other study ID #: H-0412-138-005
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2011
• Last updated: July 15, 2011
• Start date: December 2004
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Description:

The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• unresectable locally advanced pancreatic cancer

• no distant metastasis

• histologically confirmed adenocarcinoma of pancreas

• 18-75 of age

• ECOG performance status 0-2

• normal marrow function :

• WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• normal liver function :

--Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)

• normal renal function :

--Creatinine no greater than 1.5 times ULN

• signed informed consent

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine, cisplatin, capecitabine
Gemcitabine: 1000mg/? (day 1, 8), cisplatin 60mg/? (day 1) Capecitabine: 650mg/? twice a day, during radiotherapy Gemcitabine: 1000mg/? (day 1, 8)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		12 months	No
Secondary	safety	number of patients who experienced grade 3-4 toxicity by NCI-CTCAE	12 months	Yes
Secondary	1 year survival rate		1 year	No
Secondary	response rate	response rate by RECIST criteria	1 year	No
Secondary	overall survival		1 year	No
Secondary	clinical benefit rate	CR+PR+SD by RECIST criteria	1 year	No