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

NCT02545322 | Completed Results

• 1 other identifier: BART 1.1
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans. It is investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Planning Target Volume (PTV) Coverage Parameter D98%

  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.

  week 5

Secondary Outcomes (1)

• Volumetric Changes

  week 5

Study Arms (1)

Adaptive Radiotherapy

EXPERIMENTAL

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.

Radiation: Follow-up CT scans during week 3 and week 5 of treatment

Interventions

Follow-up CT scans during week 3 and week 5 of treatment RADIATION

Scheduled follow-up planning CT scan and re-optimisation of the intensity modulation radiation therapy (IMRT)-based radiotherapy Treatment plan. Dosimetric Evaluation and assessment of morphologic changes.

Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histo-pathologically verified malignancies in the head-and-neck without clinical signs of dissemination, who consented in radiotherapy or radio-chemotherapy.

You may not qualify if:

• previous radiation therapy for head-and-neck

Sponsors & Collaborators

• Medical University of Graz: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Peter Winkler, PhD (Head of Medical Physics)
• Organization: Department of Therapeutic Radiology and Oncology, Medical University of Graz

peter.winkler@medunigraz.at

+43 316 385

Study Officials

• Karin S Kapp, MD, Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: September 9, 2015
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02