Trial Outcomes & Findings for Image Guided Adaptive Radiotherapy in the Head-and-neck Region (NCT NCT02545322)

Results Overview

Dose coverage of the planning target volume: Number of participants with a decrease in the planning target volume (PTV) coverage (D98%) above 5%. The Parameter "D98%" denotes the minimum dose to 98% of the volume according to the ICRU (International Commission on Radiation Units \& Measurements) Report No. 62. It is a widely accepted classification index for dose coverage. The "Planing Target Volume" is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

week 5

Results posted on

2017-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Adaptive Radiotherapy Follow-up CT scans during week 3 and week 5 of Treatment Image-guided adaptive Radiotherapy arm: Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed.
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Adaptive Radiotherapy Follow-up CT scans during week 3 and week 5 of Treatment Image-guided adaptive Radiotherapy arm: Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Image Guided Adaptive Radiotherapy in the Head-and-neck Region

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adaptive Radiotherapy n=18 Participants Follow-up CT scans during week 3 and week 5 of Treatment Image-guided adaptive Radiotherapy arm: Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 9.1 • n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Region of Enrollment Austria	18 participants n=99 Participants

PRIMARY outcome

Timeframe: week 5

Dose coverage of the planning target volume: Number of participants with a decrease in the planning target volume (PTV) coverage (D98%) above 5%. The Parameter "D98%" denotes the minimum dose to 98% of the volume according to the ICRU (International Commission on Radiation Units \& Measurements) Report No. 62. It is a widely accepted classification index for dose coverage. The "Planing Target Volume" is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose.

Outcome measures

Outcome measures
Measure	Adaptive Radiotherapy n=15 Participants Follow-up CT scans during week 3 and week 5 of Treatment Image-guided adaptive Radiotherapy arm: Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed.
Planning Target Volume (PTV) Coverage Parameter D98%	7 participants

SECONDARY outcome

Timeframe: week 5

Percent changes in the volume of the Planning Target Volume (PTV). The "Planning Target Volume" is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose. The volumetric changes of the PTV throughout the course of Radiation therapy are evaluated. A significant change in the volume of the PTV (measured in ccm) might be an indicator for possible undesireable dosimetric alterations.

Outcome measures

Outcome measures
Measure	Adaptive Radiotherapy n=15 Participants Follow-up CT scans during week 3 and week 5 of Treatment Image-guided adaptive Radiotherapy arm: Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed.
Volumetric Changes	-4.3 percent Standard Deviation 5.4

Adverse Events

Adaptive Radiotherapy

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

Peter Winkler, PhD (Head of Medical Physics)

Department of Therapeutic Radiology and Oncology, Medical University of Graz

Phone: +43 316 385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place