Intra- and Inter-fraction Changes in Radiation Therapy | NCT02344121

Studies
Intra- and Inter-fraction Changes in Radiation Therapy

NCT02344121

Sponsor

Medical College of Wisconsin

Status

Recruiting

Last Update Posted

May 6, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Radiation Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Mar 20, 2028Estimated

First Submitted Date

Dec 5, 2014

First Submission Date that Met QC Criteria

Jan 16, 2015

First Posted Date

Jan 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation Therapy	Radiation	Radiation therapy plans for cancer patients who have completed treatment.

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

°Completed radiation therapy

Exclusion Criteria:

°Subjects who refuse voluntary participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cancer patients who have completed treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medical College of Wisconsin Cancer Center Clinical Trials Office	Contact	414-805-8900		cccto@mcw.edu
Eric Paulson, PhD	Contact	805-4400		epaulson@mcw.edu

Overall Officials

Name	Affiliation	Role
Eric Paulson, PhD	Medical College of Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Froedtert Hospital	Recruiting	Milwaukee	Wisconsin	53226	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided