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

NCT01711580 | Withdrawn DMC

• 1 other identifier: 12-01-25/01-intern-6810
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anaplastic Astrocytoma; Glioblastoma Multiforme; Anaplastic Oligoastrocytoma

Keywords

Recurrent glioma; Quality of life; Glioblastoma multiforme; Anaplastic glioma; Cognition; Re-irradiation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters

  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

  baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks

Secondary Outcomes (2)

• Overall survival of patients with glioblastoma and anaplastic glioma after re-irradiation

  6 months after the last patient is included

• Progression free survival of patients with glioblastoma and anaplastic glioma after re-irradiation

  6 months after the last patient is included

Study Arms (1)

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; 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)

Interventions

EORTC QLQ-C30 OTHER

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.

Re-irradiation, high grade glioma

EORTC QLQ-BN20 OTHER

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.

Re-irradiation, high grade glioma

Hopkins Verbal Learning Test-Revised (HVLT-R) OTHER

The HVLT-R is a cognitive test to assess verbal learning and memory.

Re-irradiation, high grade glioma

Stroop color-word test OTHER

The Stroop Color and Word Test is a brief five minute test which is used to assess brain dysfunction, cognition, and psychopathology.

Re-irradiation, high grade glioma

Controlled oral word association test (COWA) OTHER

The COWA is a measure of verbal fluency that requires expressive language and executive functions.

Re-irradiation, high grade glioma

Jamar hand dynamometer OTHER

The Jamar hand dynamometer is a screening instrument that is used to assess grip strength.

Re-irradiation, high grade glioma

EORTC QLQ- FA13 OTHER

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

Re-irradiation, high grade glioma

Trail Making Test (TMT) OTHER

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.

Re-irradiation, high grade glioma

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Life expectancy \< 3 months

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, 6229 ET, Netherlands

Location

Related Publications (23)

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MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Glioma

Interventions

Neuropsychological Tests; Trail Making Test

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Brigitta Baumert, MD, MBA

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 22, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

NL (1)