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Serial CT Scans in Fractionated Stereotactic Radiotherapy

This study has been completed.
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00181350
First received: September 9, 2005
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups.


Condition Intervention Phase
Brain Tumor
Device: Relocatable fixation system
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.

Secondary Outcome Measures:
  • No secondary measures.

Estimated Enrollment: 20
Study Start Date: November 2003
Study Completion Date: July 2007
Detailed Description:

Stereotactic conformal radiotherapy (SCRT) combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation. This implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch + 30 times. In the use of stereotactic conformal radiotherapy (SCRT) accuracy is the mainstay for the treatment of brain tumours. The reason are reduced safety margins around the tumour (or no margins) in order to reduce normal tissue dose.

This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups. The first approach will be based on the BrainLAB thermoplastic masque (the masque with (= standard fixation) and without a custom made bite-block), the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system.

Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above.

The rationale is to determine the margins to define the planning target volume (PTV), it is necessary to know the set-up accuracy of the immobilization system. An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss.

The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of brain tumor
  • Fractionated stereotactic radiotherapy

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181350

Locations
Netherlands
Maastricht Radiation Oncology
Heerlen, Limburg, Netherlands, 6419 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: Brigitta Baumert, PHD Maastricht Radiation Oncology
  More Information

No publications provided by Maastricht Radiation Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00181350     History of Changes
Other Study ID Numbers: P03.1426L
Study First Received: September 9, 2005
Last Updated: June 29, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
brain tumor
fractionated stereotactic radiotherapy
fixationsystems
repositioning

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014