Anaplastic AstrocytomaNCT01711580
Re-irradiation of High Grade Gliomas: a Quality of Life Study
An observational study of Anaplastic Astrocytoma and Glioblastoma Multiforme, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Astrocytoma, Glioblastoma Multiforme, Anaplastic Oligoastrocytoma
- What is being tested?
- EORTC QLQ-C30, EORTC QLQ-BN20 and Hopkins Verbal Learning Test-Revised (HVLT-R)
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Life expectancy < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Current treatment regimes, with the addition of temozolomide, have improved progression-free survival as well as overall survival for patients with a high grade glioma. The median overall survival (MOS) for patients with a glioblastoma (GBM) is 14.6 months, with a progression free survival (PFS) of 6.9 months.
Due to longer survival and a better performance status, patients often reach a point at which re-treatment is feasible. Treatment options for recurrent glioblastoma and anaplastic glioma can include surgery, chemotherapy and re-irradiation. Re-irradiation of patients with recurrent high grade glioma is slowly becoming standard of care. It provides a comparable overall survival to palliative chemotherapy. In case of GBM there is a median time to progression after treatment of 20-27 weeks and a MOS of 26 to 60 weeks.
Patients with tumor recurrence have a significantly worse quality of life compared to patients without recurrence at the same follow-up. They experience significantly more problems with physical functioning (e.g. motor dysfunction, weakness of legs, visual disorders), work or other daily activities, mental health (e.g. future uncertainty) and general health.
With regard to re-irradiation, current available data is mostly provided by retrospective studies which often lack solid quality of life data. Endpoints include e.g. performance status, clinical (neurological) status and decreased steroid requirement after treatment. These endpoints are however inadequate to determine quality of life accurately.
Several studies have used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) and the brain cancer module (QLQ-BN20) scales to assess quality of life. The latter consists of 20 items including visual disorder, motor dysfunction, various disease symptoms, treatment toxicity and future uncertainty. A change of 10 points or more on these scales can be considered clinically relevant.
To date only Ernst-Stecken and colleagues have used the EORTC QLQ-C30 to prospectively evaluate the quality of life in patients with a recurrent malignant glioma after radiotherapy. In this study patients were treated with hypofractionation. The quality of life questionnaire score could be kept stable in two thirds of patients with a median follow-up of 9 months. They conclude that hypofractionated stereotactic radiotherapy is an effective treatment that helps to maintain quality of life for an acceptable period, comparable to the results found with chemotherapeutic regimes.
In patients with glioma, the tumor, radiotherapy as well as chemotherapy can disrupt cognitive function. Cognitive functioning can be evaluated by a cognitive screening instrument and/or comprehensive neuropsychological test batteries. The most well-known and convenient screening instrument is the Mini Mental-State Examination (MMSE). However, the MMSE is developed to assess dementia and does not include items related to executive function. As such, the MMSE is insufficient to assess frontal-subcortical network dysfunction associated with cognitive damage after irradiation. More sensitive cognitive tests should be administered to determine the effects of re-irradiation on cognition. There is however still little consensus on which test should be used. Although comprehensive neuropsychological test batteries are most sensitive, a brief cognitive screening is preferable in the present setting. For this trial, the investigators intend to use a number of relevant standard tests including the Hopkins Verbal Learning Test-Revised (HVLT-R, the Trail Making Test and Controlled Oral Word Association (COWA) as suggested by the Radiation Therapy Oncology Group (RTOG). The Stroop colour-word test (Stroop) is added to the battery in order to assess visual attention.
Physical functioning has a major impact on quality of life in patients with cancer. A number of studies have investigated the effects of exercise on physical functioning. They have shown, predominantly in patients with breast cancer, that exercise has beneficial effects on health and well-being. Physical performance can be measured by several means. The hand grip strength (HGS) test has been validated in previous studies for the evaluation of general health status. This test is performed with the Jamar hand dynamometer which displays hand strength in kilograms. By comparing data after re-irradiation to the data collected before the treatment the amount of muscle strength loss can be determined.
Another method of measuring physical performance is by analyzing fatigue. This is a very common symptom in cancer patients and negatively influences their quality of life. Fatigue in patients with cancer can be determined with the use of both the EORTC QLQ-C30 and the more specific Fatigue Questionnaire (EORTC QLQ-FA13).
- Being tested
- EORTC QLQ-C30, EORTC QLQ-BN20, Hopkins Verbal Learning Test-Revised (HVLT-R), Stroop color-word test, Controlled oral word association test (COWA)
- Keywords
- Recurrent glioma, Quality of life, Glioblastoma multiforme, Anaplastic glioma, Cognition, Re-irradiation
- Medical subject headings
- Astrocytoma, Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-C30Other
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.
EORTC QLQ-BN20Other
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.
Hopkins Verbal Learning Test-Revised (HVLT-R)Other
The HVLT-R is a cognitive test to assess verbal learning and memory.
Stroop color-word testOther
The Stroop Color and Word Test is a brief five minute test which is used to assess brain dysfunction, cognition, and psychopathology.
Controlled oral word association test (COWA)Other
The COWA is a measure of verbal fluency that requires expressive language and executive functions.
Jamar hand dynamometerOther
The Jamar hand dynamometer is a screening instrument that is used to assess grip strength.
EORTC QLQ- FA13Other
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- Months from the start of re-irradiation to death
Measured: 6 months after the last patient is included
Progression free survival of patients with glioblastoma and anaplastic glioma after re-irradiation
- Months from the start of re-irradiation to tumorprogression
Measured: 6 months after the last patient is included
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: Another study was commenced for this patient group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitta Baumert, MD, MBA, Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711580
- Sponsor's protocol ID
- 12-01-25/01-intern-6810
- Status last verified
- May 2015
- First submitted
- 12 Oct 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PubMed 15758009Nieder C, Adam M, Molls M, Grosu AL. Therapeutic options for recurrent high-grade glioma in adult patients: recent advances. Crit Rev Oncol Hematol. 2006 Dec;60(3):181-93. doi: 10.1016/j.critrevonc.2006.06.007. Epub 2006 Jul 27.
PubMed 16875833Veninga T, Langendijk HA, Slotman BJ, Rutten EH, van der Kogel AJ, Prick MJ, Keyser A, van der Maazen RW. Reirradiation of primary brain tumours: survival, clinical response and prognostic factors. Radiother Oncol. 2001 May;59(2):127-37. doi: 10.1016/s0167-8140(01)00299-7.
PubMed 11325440Hudes RS, Corn BW, Werner-Wasik M, Andrews D, Rosenstock J, Thoron L, Downes B, Curran WJ Jr. A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. Int J Radiat Oncol Biol Phys. 1999 Jan 15;43(2):293-8. doi: 10.1016/s0360-3016(98)00416-7.
PubMed 10030252Cho KH, Hall WA, Gerbi BJ, Higgins PD, McGuire WA, Clark HB. Single dose versus fractionated stereotactic radiotherapy for recurrent high-grade gliomas. Int J Radiat Oncol Biol Phys. 1999 Dec 1;45(5):1133-41. doi: 10.1016/s0360-3016(99)00336-3.
PubMed 10613305Ernst-Stecken A, Ganslandt O, Lambrecht U, Sauer R, Grabenbauer G. Survival and quality of life after hypofractionated stereotactic radiotherapy for recurrent malignant glioma. J Neurooncol. 2007 Feb;81(3):287-94. doi: 10.1007/s11060-006-9231-0. Epub 2006 Sep 20.
PubMed 17031558Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139.
PubMed 9440735Maringwa J, Quinten C, King M, Ringash J, Osoba D, Coens C, Martinelli F, Reeve BB, Gotay C, Greimel E, Flechtner H, Cleeland CS, Schmucker-Von Koch J, Weis J, Van Den Bent MJ, Stupp R, Taphoorn MJ, Bottomley A; EORTC PROBE Project and Brain Cancer Group. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011 Sep;22(9):2107-2112. doi: 10.1093/annonc/mdq726. Epub 2011 Feb 15.
PubMed 21324954King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996 Dec;5(6):555-67. doi: 10.1007/BF00439229.
PubMed 8993101Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Meyers CA, Wefel JS. The use of the mini-mental state examination to assess cognitive functioning in cancer trials: no ifs, ands, buts, or sensitivity. J Clin Oncol. 2003 Oct 1;21(19):3557-8. doi: 10.1200/JCO.2003.07.080. Epub 2003 Aug 11. No abstract available.
PubMed 12913103Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Meyers CA, Smith JA, Bezjak A, Mehta MP, Liebmann J, Illidge T, Kunkler I, Caudrelier JM, Eisenberg PD, Meerwaldt J, Siemers R, Carrie C, Gaspar LE, Curran W, Phan SC, Miller RA, Renschler MF. Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol. 2004 Jan 1;22(1):157-65. doi: 10.1200/JCO.2004.05.128.
PubMed 14701778Olson RA, Iverson GL, Carolan H, Parkinson M, Brooks BL, McKenzie M. Prospective comparison of two cognitive screening tests: diagnostic accuracy and correlation with community integration and quality of life. J Neurooncol. 2011 Nov;105(2):337-44. doi: 10.1007/s11060-011-0595-4. Epub 2011 Apr 26.
PubMed 21520004Conn VS, Hafdahl AR, Porock DC, McDaniel R, Nielsen PJ. A meta-analysis of exercise interventions among people treated for cancer. Support Care Cancer. 2006 Jul;14(7):699-712. doi: 10.1007/s00520-005-0905-5. Epub 2006 Jan 31.
PubMed 16447036
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-irradiation of High Grade Gliomas: a Quality of Life Study
- ClinicalTrials.gov ID
- NCT01711580
- Acronym / sponsor ID
- 12-01-25/01-intern-6810
- Keywords
- Recurrent glioma, Quality of life, Glioblastoma multiforme, Anaplastic glioma, Cognition, Re-irradiation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Another study was commenced for this patient group
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current treatment regimes, with the addition of temozolomide, have improved progression-free survival as well as overall survival for patients with a high grade glioma. The median overall survival (MOS) for patients with a glioblastoma (GBM) is 14.6 months, with a progression free survival (PFS) of 6.9 months.
Due to longer survival and a better performance status, patients often reach a point at which re-treatment is feasible. Treatment options for recurrent glioblastoma and anaplastic glioma can include surgery, chemotherapy and re-irradiation. Re-irradiation of patients with recurrent high grade glioma is slowly becoming standard of care. It provides a comparable overall survival to palliative chemotherapy. In case of GBM there is a median time to progression after treatment of 20-27 weeks and a MOS of 26 to 60 weeks.
Patients with tumor recurrence have a significantly worse quality of life compared to patients without recurrence at the same follow-up. They experience significantly more problems with physical functioning (e.g. motor dysfunction, weakness of legs, visual disorders), work or other daily activities, mental health (e.g. future uncertainty) and general health.
With regard to re-irradiation, current available data is mostly provided by retrospective studies which often lack solid quality of life data. Endpoints include e.g. performance status, clinical (neurological) status and decreased steroid requirement after treatment. These endpoints are however inadequate to determine quality of life accurately.
Several studies have used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) and the brain cancer module (QLQ-BN20) scales to assess quality of life. The latter consists of 20 items including visual disorder, motor dysfunction, various disease symptoms, treatment toxicity and future uncertainty. A change of 10 points or more on these scales can be considered clinically relevant.
To date only Ernst-Stecken and colleagues have used the EORTC QLQ-C30 to prospectively evaluate the quality of life in patients with a recurrent malignant glioma after radiotherapy. In this study patients were treated with hypofractionation. The quality of life questionnaire score could be kept stable in two thirds of patients with a median follow-up of 9 months. They conclude that hypofractionated stereotactic radiotherapy is an effective treatment that helps to maintain quality of life for an acceptable period, comparable to the results found with chemotherapeutic regimes.
In patients with glioma, the tumor, radiotherapy as well as chemotherapy can disrupt cognitive function. Cognitive functioning can be evaluated by a cognitive screening instrument and/or comprehensive neuropsychological test batteries. The most well-known and convenient screening instrument is the Mini Mental-State Examination (MMSE). However, the MMSE is developed to assess dementia and does not include items related to executive function. As such, the MMSE is insufficient to assess frontal-subcortical network dysfunction associated with cognitive damage after irradiation. More sensitive cognitive tests should be administered to determine the effects of re-irradiation on cognition. There is however still little consensus on which test should be used. Although comprehensive neuropsychological test batteries are most sensitive, a brief cognitive screening is preferable in the present setting. For this trial, the investigators intend to use a number of relevant standard tests including the Hopkins Verbal Learning Test-Revised (HVLT-R, the Trail Making Test and Controlled Oral Word Association (COWA) as suggested by the Radiation Therapy Oncology Group (RTOG). The Stroop colour-word test (Stroop) is added to the battery in order to assess visual attention.
Physical functioning has a major impact on quality of life in patients with cancer. A number of studies have investigated the effects of exercise on physical functioning. They have shown, predominantly in patients with breast cancer, that exercise has beneficial effects on health and well-being. Physical performance can be measured by several means. The hand grip strength (HGS) test has been validated in previous studies for the evaluation of general health status. This test is performed with the Jamar hand dynamometer which displays hand strength in kilograms. By comparing data after re-irradiation to the data collected before the treatment the amount of muscle strength loss can be determined.
Another method of measuring physical performance is by analyzing fatigue. This is a very common symptom in cancer patients and negatively influences their quality of life. Fatigue in patients with cancer can be determined with the use of both the EORTC QLQ-C30 and the more specific Fatigue Questionnaire (EORTC QLQ-FA13).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Re-irradiation, high grade glioma | – | 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)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Life expectancy < 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-C30The 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 | Re-irradiation, high grade glioma |
| EORTC QLQ-BN20The 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 | Re-irradiation, high grade glioma |
| Hopkins Verbal Learning Test-Revised (HVLT-R)The HVLT-R is a cognitive test to assess verbal learning and memory. | Other | Re-irradiation, high grade glioma |
| Stroop color-word testThe Stroop Color and Word Test is a brief five minute test which is used to assess brain dysfunction, cognition, and psychopathology. | Other | Re-irradiation, high grade glioma |
| Controlled oral word association test (COWA)The COWA is a measure of verbal fluency that requires expressive language and executive functions. | Other | Re-irradiation, high grade glioma |
| Jamar hand dynamometerThe Jamar hand dynamometer is a screening instrument that is used to assess grip strength. | Other | Re-irradiation, high grade glioma |
| EORTC QLQ- FA13The 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 | Re-irradiation, high grade glioma |
| 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. | Other | Re-irradiation, high grade glioma |
Primary outcome
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
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
2 secondary outcomes
Overall survival of patients with glioblastoma and anaplastic glioma after re-irradiation
Time frame: 6 months after the last patient is included
Progression free survival of patients with glioblastoma and anaplastic glioma after re-irradiation
Time frame: 6 months after the last patient is included
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 15758009Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Background: PubMed 16875833Nieder C, Adam M, Molls M, Grosu AL. Therapeutic options for recurrent high-grade glioma in adult patients: recent advances. Crit Rev Oncol Hematol. 2006 Dec;60(3):181-93. doi: 10.1016/j.critrevonc.2006.06.007. Epub 2006 Jul 27.
- Background: PubMed 11325440Veninga T, Langendijk HA, Slotman BJ, Rutten EH, van der Kogel AJ, Prick MJ, Keyser A, van der Maazen RW. Reirradiation of primary brain tumours: survival, clinical response and prognostic factors. Radiother Oncol. 2001 May;59(2):127-37. doi: 10.1016/s0167-8140(01)00299-7.
- Background: PubMed 10030252Hudes RS, Corn BW, Werner-Wasik M, Andrews D, Rosenstock J, Thoron L, Downes B, Curran WJ Jr. A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. Int J Radiat Oncol Biol Phys. 1999 Jan 15;43(2):293-8. doi: 10.1016/s0360-3016(98)00416-7.
- Background: PubMed 10613305Cho KH, Hall WA, Gerbi BJ, Higgins PD, McGuire WA, Clark HB. Single dose versus fractionated stereotactic radiotherapy for recurrent high-grade gliomas. Int J Radiat Oncol Biol Phys. 1999 Dec 1;45(5):1133-41. doi: 10.1016/s0360-3016(99)00336-3.
- Background: PubMed 17031558Ernst-Stecken A, Ganslandt O, Lambrecht U, Sauer R, Grabenbauer G. Survival and quality of life after hypofractionated stereotactic radiotherapy for recurrent malignant glioma. J Neurooncol. 2007 Feb;81(3):287-94. doi: 10.1007/s11060-006-9231-0. Epub 2006 Sep 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitta Baumert, MD, MBA principal investigator
Maastro Clinic, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaplastic Astrocytoma and Glioblastoma Multiforme, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01711580, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.