Irinotecan, Gemcitabine and Radiation Therapy for Pancrea... | NCT00192712

Studies
Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

NCT00192712

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Nov 10, 2010Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Pancreatic Cancer

Interventions

irinotecan, gemcitabine

Countries

Israel

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

Sep 2010

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

Nov 2002

Primary Completion Date

Not provided

Completion Date

Sep 2010Actual

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 19, 2005Estimated

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

Nov 9, 2010

Last Update Posted Date

Nov 10, 2010Estimated

Description Module

Brief Summary

The study hypothesis is that chemoradiation based on 2 drugs will improve local control and long-term survival in patients with locally advanced pancreatic cancer. That is why gemcitabine and irinotecan are combined in an induction phase of 2 months and then this IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with irradiation.

Detailed Description

Not provided

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
irinotecan, gemcitabine	Drug

Measure	Description	Time Frame
time to treatment failure

Measure	Description	Time Frame
response rate, survival, toxicity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

locally advanced pancreatic cancer
performance status 0-2
normal blood count and chemistry
no previous chemotherapy or radiotherapy

Exclusion Criteria:

serious concurrent systemic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Epelbaum, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Rambam Medical Center		Haifa		31096	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D002277	Carcinoma

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
D000077146	Irinotecan
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D003841	Deoxycytidine

Browse Leaves

Not provided

Browse Branches

Not provided