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Chemoradiation in Locally Advanced Pancreatic Cancer

NCT00262951 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-12-28

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Conditions

Interventions

BIOLOGICAL

recombinant interferon alfa

administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1

DRUG

cisplatin

administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1

DRUG

fluorouracil

administered at a dose of 175 mg/m\^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m\^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3

RADIATION

radiation therapy

5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).

PROCEDURE

Resection of tumor

After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Edward W. Greeno, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2011-04-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00262951 on ClinicalTrials.gov