Intra- and Inter-fraction Changes in Radiation Therapy

Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor target volumes and surrounding normal organs in radiation therapy.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Radiation: Radiation Therapy

Detailed Description

The accurate and detailed knowledge of the changes (e.g., anatomically/biologically intra- and inter-fraction changes) to be obtained from this study would allow the research team to determine how Adaptive Radiation Therapy (ART) should be performed for a given tumor site/type. Radiation oncologists then can choose a proper ART strategy for a given tumor type to account for the anatomic/biological intra- and inter-fraction changes, improving accuracy of radiation therapy delivery, and in turn reducing treatment related toxicities and/or improving tumor local control.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Eric Paulson, PhD; Phone Number: 805-4400; Email: epaulson@mcw.edu
• Study Contact Backup: Name: Medical College of Wisconsin Cancer Center Clinical Trials Office; Phone Number: 414-805-8900; Email: cccto@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital
      • Contact: Eric Paulson, PhD; Phone Number: 414-805-4400; Email: ali@mcw.edu
      • Principal Investigator: Eric Paulson, PhD
      • Contact: PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients who have completed treatment.

Description

Inclusion Criteria:

°Completed radiation therapy

Exclusion Criteria:

°Subjects who refuse voluntary participation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of volumes from baseline of organs at risk during and after radiation therapy.	Changes of organs at risk volumes (cm^3) during and after radiation therapy.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of volumes from baseline or tumors during and after radiation therapy.	Changes of tumor volumes (cm^3) during and after radiation therapy.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive radiation therapy plans	Determine the best strategy -- real time, online or offline, margins, replanning methods for adaptive radiation therapy treatment plans.	2 years

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Eric Paulson, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimated): January 22, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 22316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No