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OpenTrials
Completed

NCT Number: NCT00191568

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

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.

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

Oxaliplatin

Drug

Radiotherapy

Procedure

Primary outcomes

  1. To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Oct 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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