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

Study Overview

Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)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.

N/A

Pancreatic Cancer

RADIATION: INTENSITY MODULATED RADIOTHERAPY
DRUG: Gemcitabine

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

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 2008-01-02	Results First Submitted 2014-08-12	Last Update Submitted that met QC Criteria 2015-08-28
First Submitted that Met QC Criteria 2008-01-14	Results First Submitted that Met QC Criteria 2014-08-12	Last Update Posted (ESTIMATED) 2015-09-11
First Posted (ESTIMATED) 2008-01-15	Results First Posted 2014-08-27	Last Verified 2015-08

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: 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	RADIATION: INTENSITY MODULATED RADIOTHERAPY Five fractions weekly, fraction size determined by dose level DRUG: Gemcitabine 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

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

RADIATION: INTENSITY MODULATED RADIOTHERAPY

Five fractions weekly, fraction size determined by dose level

DRUG: Gemcitabine

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Primary Outcome Measures	Measure Description	Time Frame
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.	13 weeks post radiation

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

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

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

Collaborators and Investigators

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

Rush University Medical Center

Investigators

PRINCIPAL_INVESTIGATOR: Mark Zalupski, MD, University of Michigan

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

No publications available

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Resources

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Clinical Trial Record