Trial Outcomes & Findings for A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy (NCT NCT02130427)

NCT ID: NCT02130427

Last Updated: 2022-07-22

Results Overview

The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: 9 weeks
• Results posted on: 2022-07-22

Participant Flow

Participant milestones

Measure	Imaging Weekly 3D/4D CT scans while receiving radiation therapy. Radiation therapy dosage metrics were not collected.
Overall Study STARTED	74
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	Imaging Weekly 3D/4D CT scans while receiving radiation therapy. Radiation therapy dosage metrics were not collected.
Overall Study Imaging results not interpretable	30

Baseline Characteristics

A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy

Baseline characteristics by cohort

Measure	Imaging n=44 Participants Weekly 3D/4D CT scans; MRI scans used at the discretion of the treating physician when the location of the tumor requires it.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Tumor volume	141.3 cm^3 STANDARD_DEVIATION 158.4 • n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging.

Outcome measures

Measure	Completed Imaging n=44 Participants Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician. CT scan: Weekly 3D/4D CT scan
Tumor Volume	93.55 cm^3 Standard Deviation 63.77

Adverse Events

Complete Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wei Zou

University of Pennsylvania

Phone: 800-789-7366

Email: Wei.Zou@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place