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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Gemcitabine

Oxaliplatin

Radiotherapy

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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
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
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
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
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
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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT00191568

First Posted

September 12, 2005

Last Updated

October 18, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00191568

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Type

Procedure

Intervention Name(s)

Radiotherapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name