Fixed Dose Rate Gemcitabine and Cisplatin Followed by Che... | NCT01396668

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

NCT01396668

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 19, 2011Estimated

Enrollment

35Estimated

Phase

Phase 2

Conditions

Pancreatic Cancer

Interventions

gemcitabine, cisplatin, capecitabine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 1, 2011

First Submission Date that Met QC Criteria

Jul 15, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2011

Last Update Posted Date

Jul 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine, cisplatin, capecitabine	Drug	Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression		12 months

Secondary Outcomes

Measure	Description	Time Frame
safety	number of patients who experienced grade 3-4 toxicity by NCI-CTCAE	12 months
1 year survival rate		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seock-Ah Im, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam			South Korea
Seoul National University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D002945	Cisplatin
D000069287	Capecitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided