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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593866
• Other study ID #: UMCC 2006.018
• Secondary ID: IRB #HUM3315
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 2, 2008
• Last updated: August 28, 2015
• Start date: June 2006
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University Of Michigan	Ann Arbor	Michigan
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The Percentage of Participants Free From Local Progression at 2 Years		2 Years	Yes