Intra- and Inter-fraction Changes in Radiation Therapy

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02344121
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Duration (Months): 180
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Intra- and Inter-fraction Changes in Radiation Therapy
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jan 1, 2030

Outcome Measures

Primary Outcome Measures

1. Changes in locations, volumes and shapes of organs at risk during and after radiation therapy [2 years]

   Changes of tumor location, shapes and volumes during and after Radiation Therapy as measured by a series of parameters including Dice Coefficient, volume ratio.

Secondary Outcome Measures

1. Tumor margins, tumor shapes and volumes during and after Radiation Therapy [2 years]

   Sizes of tumor margins determined from the changes of tumor shapes and volumes during and after Radiation Therapy.

Other Outcome Measures

1. Adaptive radiation therapy plans [2 years]

   Determine the best strategy- real time, online or offline, margins, replanning methods for Adaptive radiation therapy treatment plans.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

°Completed radiation therapy

Exclusion Criteria:

°Subjects who refuse voluntary participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Froedtert Hospital	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin

Investigators

• Principal Investigator: Allen Li, PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allen Li, Radiation Oncology Chief of Physics, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT02344121
• Other Study ID Numbers: 22316
• First Posted: Jan 22, 2015
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

Study Results

No Results Posted as of Nov 26, 2021