NCT02344121

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2015Mar 2028

First Submitted

Initial submission to the registry

December 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

13 years

First QC Date

December 5, 2014

Last Update Submit

April 30, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Changes of volumes from baseline or tumors during and after radiation therapy.

    2 years

Interventions

Radiation TherapyRADIATION

Radiation therapy plans for cancer patients who have completed treatment.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients who have completed treatment.

You may qualify if:

  • °Completed radiation therapy

You may not qualify if:

  • °Subjects who refuse voluntary participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Eric Paulson, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

414-805-8900cccto@mcw.edu

Eric Paulson, PhD

CONTACT

805-4400epaulson@mcw.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2014

First Posted

January 22, 2015

Study Start

January 1, 2015

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 20, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)