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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INTENSITY MODULATED RADIOTHERAPY
Gemcitabine
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Patients who have confirmed cancer arising from the pancreas

Eligibility Criteria

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

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

Sites / Locations

  • Rush University Medical Center
  • University Of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Dose Escalation with Gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

The Maximum Tolerated Radiation Dose
The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.

Secondary Outcome Measures

The Percentage of Participants Free From Local Progression at 2 Years

Full Information

First Posted
January 2, 2008
Last Updated
August 28, 2015
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00593866
Brief Title
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
Official Title
A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Rush University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Patients who have confirmed cancer arising from the pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Dose Escalation with Gemcitabine
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
INTENSITY MODULATED RADIOTHERAPY
Other Intervention Name(s)
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
Intervention Description
Five fractions weekly, fraction size determined by dose level
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
Primary Outcome Measure Information:
Title
The Maximum Tolerated Radiation Dose
Description
The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
Time Frame
13 weeks post radiation
Secondary Outcome Measure Information:
Title
The Percentage of Participants Free From Local Progression at 2 Years
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Zalupski, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3833
Country
United States
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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