Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00192712

Enrollment

Registered

2005-09-19

Start date

2002-11-30

Completion date

2010-09-30

Last updated

2010-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

carcinoma, pancreas, chemotherapy, radiotherapy

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.

Interventions

DRUGirinotecan, gemcitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
time to treatment failure	—

Secondary

Measure	Time frame
response rate, survival, toxicity	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026