Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer

August 28, 2015 updated by: University of Michigan Rogel Cancer Center

A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612-3833
        • Rush University Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5010
        • University of Michigan

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is the patient 18 years of age or older.
  • Does the patient have histologically or cytologically proven carcinoma of the pancreas
  • Is the tumor unresectable or medically inoperable
  • Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
  • Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
  • Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present
  • Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
  • If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
  • Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent

Exclusion Criteria:

  • Does the patient have a neuroendocrine tumor of the pancreas
  • Does the patient have metastatic disease
  • Does the patient have a history of abdominal radiation therapy
  • Is there history of more than 1 month of therapy with single agent gemcitabine
  • Has the patient used any investigational agent in the month before enrollment into the study

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation Dose Escalation with Gemcitabine

INTENSITY MODULATED RADIOTHERAPY

Radiation dose escalation:

Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4

  • BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level

Gemcitabine:

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
Radiation: INTENSITY MODULATED RADIOTHERAPY
Five fractions weekly, fraction size determined by dose level
Other Names:
  • Radiation dose escalation:
  • Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction)
  • Level 1 45.0 1.8 53.1 45.0
  • Level 2 50.0 2.0 60.0 50.4
  • Level 3 52.5 2.1 63.5 54.0
  • Level 4 55.0 2.2 67.1 57.0
  • Level 5 57.5 2.3 70.7 60.0
  • Level 6 60.0 2.4 74.4 63.0
  • Level 7 62.5 2.5 78.1 66.2
  • Level 8 65.0 2.6 81.9 69.4
  • * BED=Biological Effective Dose; =10
Drug: Gemcitabine
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Maximum Tolerated Radiation Dose
Time Frame: 13 weeks post radiation
The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
13 weeks post radiation

Secondary Outcome Measures

Outcome Measure
Time Frame
The Percentage of Participants Free From Local Progression at 2 Years
Time Frame: 2 Years
2 Years

Collaborators and Investigators

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

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Rush University Medical Center

Investigators

  • Principal Investigator: Mark Zalupski, MD, University of Michigan

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 Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2006.018
  • IRB #HUM3315 (Other Identifier: University of Michigan Medical IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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