Chemoradiation, Cognitive Decline, Glioblastoma, Radiotherapy; Complications
Conditions
Keywords
Memory, Brain Cancer, Ramipril
Brief summary
This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.
Detailed description
This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).
Interventions
DRUGRamipril
2.5 - 5 mg oral, 1x daily for 22 weeks
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization \[WHO\] grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible. * The tumor must have a supratentorial component. * History/physical examination within 14 days prior to enrollment. * The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment * Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for six weeks as per standard of care therapy. Use of the Optune® (also known as Tumor Treating Fields or TTFields) device is allowed at provider discretion, but must begin after the Month 1 Post RT (10 week \[wk\]) Neurocognitive-PRO assessment. * Study drug (Ramipril) must be given \>= 21 days and ≤ 42 days after surgery. * All available brain magnetic resonance imaging (MRI) or computed tomography (CT) imaging reports from surgery to study completion must be submitted. This includes any post-operative or pre-radiation scan reports. * Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (obtained within 14 days prior to enrollment) * Platelets \>= 100,000 cells/mm\^3 (obtained within 14 days prior to enrollment) * Hemoglobin \>= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable) (obtained within 14 days prior to enrollment) * Blood urea nitrogen (BUN) =\< 30 mg/dl within 14 days prior to enrollment * Creatinine =\< 1.7 mg/dl within 14 days prior to enrollment * Total bilirubin =\< 2.0 mg/dl within 14 days prior to enrollment * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 3 x normal range within 14 days prior to enrollment * Patient must provide study specific informed consent prior to study entry * Baseline potassium level \<5.0 mEq/L. High potassium values that are thought to be a result of sample hemolysis may be repeated to determine an accurate potassium level and to determine potential study eligibility. Likewise high potassium values thought to be a result of potassium supplementation may be repeated at an appropriate time (5 half-lives after supplement discontinuation) to determine potential study eligibility. Patient must be able to complete neurocognitive tests in the English language * Women of childbearing potential and male participants must practice adequate contraception * For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment * Local site must be follow the standard GBM radiation treatment dosimetry plan * For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following inclusion criteria also apply: * Patients must have only a supratentorial glioblastoma * The treating physician must be a qualified provider having successfully completed the training course provided by Novocure, the device manufacturer * Patients with prior malignancies if all treatment for that malignancy was completed at least 2 years before registration and the patient has no evidence of disease.
Exclusion criteria
* Prior allergic reaction or intolerance to angiotensin-converting-enzyme (ACE) inhibitor * Hypotension (\< 110 mg Hg systolic) at the time of enrollment * Renal insufficiency with creatinine clearance of \< 40 ml/min (at time of enrollment) * Solitary kidney or known renal artery stenosis * Current ACE inhibitor or angiotensin receptor blocker use. Patients can come off ACE inhibitors or angiotensin receptor blockers for 1 week to be eligible for this study. * Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 2 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible). * Recurrent or multifocal malignant gliomas * Metastases detected below the tentorium or beyond the cranial vault * Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. * Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields. * Severe active co-morbidity, defined as follows: * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment. * Known HIV positivity or acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. * Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity. * Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy. * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. * Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study unless they involve standard of care or over the counter therapies or do not involve a drug therapy. * Patients planning to receive therapeutic antitumor agents (excluding use of the Tumor Treating Fields (TTFields or Optune®) device after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment.) in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study. * Patients with impaired decision-making capacity; this exclusion is necessary because such patients may not be able to adequately give informed consent. * Pregnant or lactating women, due to possible adverse effect on the developing fetus or infant due to study drug. * For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score | Baseline,10 weeks | HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-36) for part A Total Recall is calculated as the total number of words correctly recalled amongst the three trials. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score | Baseline,10 weeks | HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-12) for part B Delayed Recall is calculated as the number of words correctly recalled. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score | Baseline,10 weeks | HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (-12-12) for part C Delayed Recognition is calculated as the number of incorrectly identified words subtracted from the number of correctly identified words. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part A (TMT A) Standardized Score | Baseline,10 weeks | Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. The raw score for TMT-A is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part B (TMT B) Standardized Score | Baseline,10 weeks | TMT-B requires subjects to connect 25 dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The raw score TMT-B is the total time in seconds required to complete the task. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Change From Baseline Neurocognitive Function at 10 Weeks - Controlled Oral Word Association Test (COWA) Standardized Scores | Baseline,10 weeks | The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter. The raw score on the COWA (0-87) is the total number of words named across the three trials minus repetitions. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary | Baseline | Shipley Institute of Living Scale provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. The score is total correct of 40 items (0-40). Higher scores indicate a better outcome. |
| Retention Rate at 10 Weeks | 10 weeks | Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Global HRQOL Scale | Baseline, 6 weeks, 10 weeks, 22 weeks | A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. |
| Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Physical Functioning Scale | Baseline, 6 weeks, 10 weeks, 22 weeks | A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. |
| Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Cognitive Functioning Scale | Baseline, 6 weeks, 10 weeks, 22 weeks | A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. |
| Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Social Functioning Scale | Baseline, 6 weeks, 10 weeks, 22 weeks | A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. |
| Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Motor Dysfunction | Baseline, 6 weeks, 10 weeks, 22 weeks | A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. |
| Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Communication Deficit | Baseline, 6 weeks, 10 weeks, 22 weeks | A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. |
| Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Total Recall | Baseline - 22 weeks | Measured by presence of a decline of the HVLT-R Total Recall standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data. |
| Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Delayed Recall | Baseline - 22 weeks | Measured by presence of a decline of the HVLT-R Delayed Recall standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data. |
| Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Recognition | Baseline - 22 weeks | Measured by presence of a decline of the HVLT-R Recognition standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data. |
| Number of Participants With Neurocognitive Decline- Trail Making Test Part A (TMT A) | Baseline - 22 weeks | Measured by presence of a decline of the TMT-A standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data. |
| Number of Participants With Neurocognitive Decline- Trail Making Test Part B (TMT B) | Baseline - 22 weeks | Measured by presence of a decline of the TMT-B standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data. |
| Number of Participants With Neurocognitive Decline- Controlled Oral Word Association Test (COWA) | Baseline - 22 weeks | Measured by presence of a decline of the COWA standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data. |
| Determine Presence of Apolipoprotein Epsilon (ApoE) | Baseline | Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test |
| Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score | 22 weeks | A comparison of HVLT-R Total Recall standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-36) for part A Total Recall is calculated as the total number of words correctly recalled amongst the three trials. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score | 22 weeks | A comparison of HVLT-R Delayed Recall standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-12) for part B Delayed Recall is calculated as the number of words correctly recalled. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score | 22 weeks | A comparison of HVLT-R Delayed Recognition standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (-12-12) for part C Delayed Recognition is calculated as the number of incorrectly identified words subtracted from the number of correctly identified words. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part A (TMT A) Standardized Score | 22 weeks | A comparison of TMT-A standardized scores between groups at study end. Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. The raw score for TMT-A is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part B (TMT B) Standardized Score | 22 weeks | A comparison of TMT-B standardized scores between groups at study end. TMT-B requires subjects to connect 25 dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The raw score TMT-B is the total time in seconds required to complete the task. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- Controlled Oral Word Association Test (COWA) Standardized Score | 22 weeks | A comparison of COWA standardized scores between groups at study end. The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter. The raw score on the COWA (0-87) is the total number of words named across the three trials minus repetitions. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Global HRQOL Scale | 22 weeks | Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Physical Functioning Scale | 22 weeks | Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Cognitive Functioning Scale | 22 weeks | Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Social Functioning Scale | 22 weeks | Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Motor Dysfunction | 22 weeks | Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. Scores are compared with the control arm of RTOG0825 (NCT00884741). |
| Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Communication Deficit | 22 weeks | Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. Scores are compared with the control arm of RTOG0825 (NCT00884741). |
Countries
Guam, United States
Contacts
PRINCIPAL_INVESTIGATORGlenn Lesser, MD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63 years |
| Baseline Symptom Burden Able to carry on normal activity, minor symptoms of disease | 15 Participants |
| Baseline Symptom Burden Care for self, unable to carry on normal activity or to do active work | 6 Participants |
| Baseline Symptom Burden Normal activity with effort, some symptoms of disease | 14 Participants |
| Baseline Symptom Burden Normal, no complaints, no symptoms of disease | 18 Participants |
| Baseline Symptom Burden Require considerable assistance for personal care | 4 Participants |
| Baseline Symptom Burden Require occasional assistance but able to care for most of personal needs | 13 Participants |
| Baseline Symptom Burden Unknown/No information | 3 Participants |
| ECOG performance status 0 | 21 Participants |
| ECOG performance status 1 | 47 Participants |
| ECOG performance status 2 | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| IDH mutation status (IDH1) Unknown | 31 Participants |
| IDH mutation status (IDH1) Wild type | 42 Participants |
| IDH mutation status (IDH2) Unknown | 43 Participants |
| IDH mutation status (IDH2) Wild type | 30 Participants |
| Medical history Cerebrovascular disease | 1 Participants |
| Medical history Chronic pulmonary disease | 1 Participants |
| Medical history Congestive heart failure | 1 Participants |
| Medical history Connective tissue disease | 0 Participants |
| Medical history Diabetes | 15 Participants |
| Medical history Hemiplegia | 2 Participants |
| Medical history HIV/AIDS | 0 Participants |
| Medical history Hypertension requiring medication | 27 Participants |
| Medical history Liver disease | 2 Participants |
| Medical history Myocardial infarction | 0 Participants |
| Medical history None | 17 Participants |
| Medical history Other cancer | 9 Participants |
| Medical history Other medical conditions | 38 Participants |
| Medical history Peptic ulcer disease | 0 Participants |
| Medical history Peripheral vascular disease | 0 Participants |
| No measurable disease | 37 Participants |
| Number of times fallen in the last 6 months | 0.76 count STANDARD_DEVIATION 1.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 49 Participants |
| Site of Lesion Basal ganglia | 2 Participants |
| Site of Lesion Frontal | 20 Participants |
| Site of Lesion Multiple | 10 Participants |
| Site of Lesion None | 5 Participants |
| Site of Lesion Occipital | 3 Participants |
| Site of Lesion Parietal | 11 Participants |
| Site of Lesion Temporal | 22 Participants |
| Tumor laterality Left | 35 Participants |
| Tumor laterality Missing | 6 Participants |
| Tumor laterality Right | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 75 |
| other Total, other adverse events | 31 / 75 |
| serious Total, serious adverse events | 8 / 75 |
Outcome results
None listed