Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments standard radiation therapy, active breathing control device (abc), computed tomography scan (ct)
Sponsor University of Michigan Cancer Center
Start date January 2012
End date October 2016
Trial size 39 participants
Trial identifier NCT01986738, HUM00050677, NCT01832142, UMCC 2011.055

Summary

This is a study to assess the motion of pancreatic tumors during radiation therapy using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC)
standard radiation therapy
Radiotherapy will be planned and delivered according to institutional standard of care.
active breathing control device (abc)
computed tomography scan (ct)

Primary Outcomes

Measure
Distance traveled by the pancreatic tumor during radiation treatment using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device
time frame: Weeks -3 to -1, Week 1, Week 3, Week 5
Distance traveled by the pancreatic tumor between radiation treatments using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device
time frame: Week -3 to -1, Week 1, Week 3, Week 5

Secondary Outcomes

Measure
Probability of surrounding normal tissue being a particular distance from the tumor marker at any time point.
time frame: Week -1 to -3, Week 1, Week 3, Week 5
Assess the impact of the determined treatment margins on the radiation dose to normal tissues and the ability to escalate dose to the tumor using Intensity-Modulated Radiation Therapy (IMRT)
time frame: Analysis will take place after treatment at approximately week 6

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients ≥ 18 years of age - A working diagnosis (with or without histologic confirmation) of pancreatic cancer - A plan to treat with radiotherapy (or chemoradiotherapy) - Patients must have fiducial marker(s) endoscopically placed within the pancreas for clinical treatment. Exclusion Criteria: - Previous abdominal radiotherapy. - Patients with a history of major abdominal surgery. - Patients who are pregnant.

Additional Information

Official title A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control Device (ABC) in Patients With Pancreatic Cancer
Principal investigator Mary Feng, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.