NCT00593866

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-06-01
• Primary completion: 2012-05-01
• Completion: 2014-10-01
• First posted: 2008-01-15
• Last updated: 2015-09-11
• Results posted: 2014-08-27

Locations

2 sites across 1 country: United States