NCT01396668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

6.5 years

First QC Date

July 1, 2011

Last Update Submit

July 15, 2011

Conditions

Pancreatic Cancer

Keywords

locally advanced

Outcome Measures

Primary Outcomes (1)

  • Time to progression

    12 months

Secondary Outcomes (5)

  • safety

    12 months

  • 1 year survival rate

    1 year

  • response rate

    1 year

  • overall survival

    1 year

  • clinical benefit rate

    1 year

Interventions

gemcitabine, cisplatin, capecitabineDRUG

Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unresectable locally advanced pancreatic cancer
  • no distant metastasis
  • histologically confirmed adenocarcinoma of pancreas
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineCisplatinCapecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Seock-Ah Im, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 19, 2011

Study Start

December 1, 2004

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

KR(2)