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Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

NCT01121848 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2014-10-27

No results posted yet for this study

Summary

Primary Objective:

To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death

Secondary Objective:

To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

Leucovorin

Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:

DRUG

OXALIPLATIN

Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen:

DRUG

5-Fluorouracil

Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121848 on ClinicalTrials.gov