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Re-irradiation of High Grade Gliomas: a Quality of Life Study

This study is not yet open for participant recruitment.
Verified February 2013 by Maastricht Radiation Oncology
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01711580
First received: October 12, 2012
Last updated: February 9, 2013
Last verified: February 2013
History of Changes
  Purpose

Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.


Condition Intervention
Anaplastic Astrocytoma
Glioblastoma Multiforme
Anaplastic Oligoastrocytoma
 Other: EORTC QLQ-C30
Other: EORTC QLQ-BN20
Other: Hopkins Verbal Learning Test-Revised (HVLT-R)
Other: Stroop color-word test
Other: Controlled oral word association test (COWA)
Other: Jamar hand dynamometer
Other: EORTC QLQ- FA13
Other: Trail Making Test (TMT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Re-irradiation of High Grade Gliomas: a Quality of Life Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters [ Time Frame: baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks ] [ Designated as safety issue: No ]

    These Quality of life parameters include:

    • The change in the EORTC QLQ-C30 score from baseline to endpoint
    • The change in the EORTC QLQ-BN20 score from baseline to endpoint
    • The change in the EORTC QLQ-FA13 score from baseline to endpoint
    • The change in cognition from baseline to endpoint as measured by the HVLT-R, the TMT, the Stroop-test and the COWA
    • The change in grip strength from baseline to endpoint


Secondary Outcome Measures:
  • Overall survival of patients with glioblastoma and anaplastic glioma after re-irradiation [ Time Frame: 6 months after the last patient is included ] [ Designated as safety issue: No ]
    - Months from the start of re-irradiation to death

  • Progression free survival of patients with glioblastoma and anaplastic glioma after re-irradiation [ Time Frame: 6 months after the last patient is included ] [ Designated as safety issue: No ]
    - Months from the start of re-irradiation to tumorprogression


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Re-irradiation, high grade glioma
EORTC QLQ-C30 EORTC QLQ-BN20 Hopkins Verbal Learning Test-Revised (HVLT-R) Trail Making Test (TMT) Stroop color-word test Controlled oral word association test (COWA) Jamar hand dynamometer EORTC QLQ- FA13 Short Form health survey (SF-36)
 Other: EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is supplemented by disease specific modules for e.g. Breast, Lung, Head & Neck, Oesophageal, Ovarian, Gastric, Cervical cancer, Multiple Myeloma, Oesophago-Gastric, Prostate, Colorectal Liver Metastases, Colorectal and Brain cancer which are distributed from the EORTC Quality of Life Department. Other disease specific modules are under development but not yet validated.
Other: EORTC QLQ-BN20
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is supplemented by disease specific modules for e.g. Breast, Lung, Head & Neck, Oesophageal, Ovarian, Gastric, Cervical cancer, Multiple Myeloma, Oesophago-Gastric, Prostate, Colorectal Liver Metastases, Colorectal and Brain cancer which are distributed from the EORTC Quality of Life Department. Other disease specific modules are under development but not yet validated.
Other: Hopkins Verbal Learning Test-Revised (HVLT-R)
The HVLT-R is a cognitive test to assess verbal learning and memory.
Other: Stroop color-word test
The Stroop Color and Word Test is a brief five minute test which is used to assess brain dysfunction, cognition, and psychopathology.
Other: Controlled oral word association test (COWA)
The COWA is a measure of verbal fluency that requires expressive language and executive functions.
Other: Jamar hand dynamometer
The Jamar hand dynamometer is a screening instrument that is used to assess grip strength.
Other: EORTC QLQ- FA13
The Fatigue Questionnaire (QLQ-FA13) is a 13-item questionnaire to assess fatigue in patients with cancer. It is meant to be used in conjunction with the EORTC QLQ-C30
Other: Trail Making Test (TMT)
The TMT The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of subjects with a histologically proven high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme) at primary diagnosis, who are now eligible for re-irradation because of a recurrence.

Criteria

Inclusion Criteria:

  • Histologically proven high-grade glioma anaplastic astrocytoma or glioblastoma
  • Age ≥ 18 years
  • WHO performance status ≤ 2
  • Scheduled for re-irradiation of a high grade glioma
  • The patient is willing and capable to comply with study procedure

Exclusion Criteria:

• Life expectancy < 3 months

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711580

Contacts
Contact: Brigitta Baumert, MD, MBA +31884455666 brigitta.baumert@maastro.nl
Contact: Inge Compter, MD +31884455666 inge.compter@maastro.nl

Locations
Netherlands
Maastricht Radiation Oncology Not yet recruiting
Maastricht, Netherlands, 6229 ET
Contact: Inge Compter, MD     +31884455666     inge.compter@maastro.nl    
Contact: Vivian Braeken, PhD     +31884455666     vivian.braeken@maastro.nl    
Sub-Investigator: Inge Compter, MD            
Sub-Investigator: Vivian Braeken, PhD            
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Brigitta Baumert, MD, MBA MAASTRO Clinic
  More Information

Publications:

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01711580     History of Changes
Other Study ID Numbers: 12-01-25/01-intern-6810
Study First Received: October 12, 2012
Last Updated: February 9, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
Recurrent glioma
Quality of life
Glioblastoma multiforme
 Anaplastic glioma
Cognition
Re-irradiation

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 23, 2013