Radiotherapy Combined With Oxaliplatin And Fluorouracil Followed By Gemcitabine In Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

Study Overview

Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.

PRIMARY OBJECTIVES: I. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine. SECONDARY OBJECTIVES: I. Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen. II. Determine toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Adenocarcinoma of the Pancreas
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer

RADIATION: radiation therapy
DRUG: oxaliplatin
DRUG: fluorouracil
DRUG: gemcitabine hydrochloride

NCI-2012-01816
N0349
CDR0000391191
NCCTG-N0349
U10CA025224 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-11-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-07-15
First Submitted that Met QC Criteria 2004-11-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-07-16
First Posted (ESTIMATED) 2004-11-09	Results First Posted N/A	Last Verified 2013-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after	RADIATION: radiation therapy Undergo radiation therapy DRUG: oxaliplatin Given IV DRUG: fluorouracil Given IV DRUG: gemcitabine hydrochloride Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I

Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after

RADIATION: radiation therapy

Undergo radiation therapy

DRUG: oxaliplatin

Given IV

DRUG: fluorouracil

Given IV

DRUG: gemcitabine hydrochloride

Given IV

Primary Outcome Measures	Measure Description	Time Frame
1-year survival rate	1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.	At 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Survival time	The distribution of survival time will be estimated using the method of Kaplan-Meier.	Time from registration to death due to any cause, assessed up to 3 years
Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart		Up to 6 months
Time to disease progression	The distribution of time to progression will be estimated using the method of Kaplan-Meier.	Time from registration to documentation of disease progression, assessed up to 3 years
Duration of response		Date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years
Time to treatment failure		Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed adenocarcinoma of the pancreas

Unresectable disease, including subtotal resection and gross residual disease
Locally advanced disease
No cystadenocarcinoma of the pancreas
No pancreatic tumors of neuroendocrine origin
No microscopic residual disease as only evidence of pancreatic cancer
All disease must be encompassable within standard radiotherapy fields for pancreatic cancer
No distant metastases (liver or lung metastases or peritoneal spread)

No evidence of metastatic disease outside the planned radiotherapy field
Performance status - ECOG 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to maintain adequate oral nutrition
No significant infection
No significant nausea or vomiting
No other medical condition that would preclude study participation
No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)
No known allergy to platinum compounds
No prior biologic therapy
No concurrent biologic therapy
No concurrent immunotherapy
No prior chemotherapy
No other concurrent chemotherapy
No prior radiotherapy that would overlap planned radiotherapy fields
No other concurrent radiotherapy
See Disease Characteristics
At least 21 days since prior laparotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: George Kim, North Central Cancer Treatment Group

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Caregivers

Clinical Trial Record