Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer

A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191568

Enrollment

Registered

2005-09-19

Start date

2002-10-31

Completion date

2007-05-31

Last updated

2007-10-19

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

Conditions

Pancreatic Neoplasms

Brief summary

A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.

Interventions

DRUGGemcitabine

DRUGOxaliplatin

PROCEDURERadiotherapy

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

* Pathologically confirmed adenocarcinoma of the pancreas * Patient have undergone a potentially curative resection * No previous irradiation to the planned field * Negative pregnancy test for child bearing women

Exclusion criteria

* Non-adenocarcinoma pancreatic cancer * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious systemic disorder * Metastatic disease * Pregnancy, breast feeding

Design outcomes

Primary

Measure	Time frame
To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study	—

Secondary

Measure	Time frame
To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)	—

Countries

France

Outcome results

None listed

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