SCLC, Small-cell Lung Cancer, Small Cell Lung Cancer Limited Stage
Conditions
Keywords
Prophylactic Cranial Irradiation, PCI, Hippocampal-sparing irradiation
Brief summary
The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.
Detailed description
The standard of care in management of small cell lung cancer consists of chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) based on a randomized trial that demonstrated a significant improvement in overall survival (OS) with PCI. Unfortunately radiation therapy to the brain is associated with neurocognitive toxicity, which may be at least in part related to radiation induced injury to neural progenitor cells in the hippocampus. Both human and animal data suggest an inverse relationship between radiation dose to the hippocampus and performance on neuropsychological testing. We hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control (RTOG 0212) receiving the same dose of conventional PCI. The primary objective of this study is to evaluate performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 6 months following hippocampal-sparing PCI relative to the historical control. Secondary objectives are to estimate: 1) composite cognitive function following hippocampal-sparing PCI relative to the historical control and 2) the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI. The long term goal of this research is to reduce the long term sequelae of radiation therapy for both primary and metastatic brain tumors.
Interventions
RADIATIONHippocampal-sparing Prophylactic Cranial Irradiation
Hippocampal-sparing Prophylactic Cranial Irradiation
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient must have newly diagnosed and confirmed small-cell lung cancer (SCLC) * Patient must have a performance status of 1 or higher * Patients must not have received previous irradiation to the brain * Patients must have limited stage disease with complete response to chemotherapy and consolidative chest radiotherapy that was documented at least on standard chest x-rays within one month of study entry * Negative MRI or CT scan of the brain at least one month before protocol entry * Women of child-bearing potential must have a negative pregnancy test and also agree to use adequate contraceptives while on protocol * Patient must be able to understand and sign the informed consent document * Patient must be informed of the investigational aspect to this trial prior to singing the informed consent document
Exclusion criteria
* Patients receiving prior external beam irradiation to the head or neck, including any form of stereotactic irradiation * Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion * Planned concurrent chemotherapy or antitumoral agent during PCI * Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix * Patients with minimal pleural effusion evident on chest X-ray; minimal pleural effusion visible on chest CT is allowed. * Patients with epilepsy requiring permanent oral medication * Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits. * Patients may not take Memantine. This is the only eligibility criterion that has been added to those of RTOG 0212, since some physicians might now prescribe Memantine. This medication would not have been given at the time of enrollment on RTOG 0212 and its administration could confound the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall | Baseline, 6 months and 12 months post radiation treatment | The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Baseline | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A & B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Baseline and 6 months post radiation treatment | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from not at all to very much. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following: * Dyspnoea * Insomnia * Appetite * Constipation * Diarrhoea * Finances * Fatigue * Nausea/Vomiting * Pain * Physical Function * Role Function * Emotional Function * Cognitive Function * Social Function * Global QoL |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Baseline and 12 months post radiation treatment | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from not at all to very much. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following: * Dyspnoea * Insomnia * Appetite * Constipation * Diarrhoea * Finances * Fatigue * Nausea/Vomiting * Pain * Physical Function * Role Function * Emotional Function * Cognitive Function * Social Function * Global QoL |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Baseline and 6 months post radiation treatment | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following: * Headaches * Seizures * Drowsy * Hair loss * Itching * Weakness * Bladder * Future Uncertainty * Visual Disorder * Motor Dysfunction * Communication Deficit |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Baseline and 12 months post radiation treatment | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following: * Headaches * Seizures * Drowsy * Hair loss * Itching * Weakness * Bladder * Future Uncertainty * Visual Disorder * Motor Dysfunction * Communication Deficit Headaches Seizures Drowsy Hair loss Itching Weakness Bladder Future Uncertainty Scale Visual Disorder Scale Motor Dysfunction Scale Communication Deficit Scale |
| Number Participants With Hippocampus Brain Metastases Following Sparing PCI | 12 months | The number of participants with brain metastases after sparing PCI treatment was assessed to be compared to two existing studies. |
| Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected | 6 months, 12 months, 18 months and 24 months post radiation treatment | Determine whether development of leptomeningeal carcinomatosis following hippocampal-sparing PCI is higher than expected. |
| Percentage of Participants Surviving Following Hippocampal-sparing PCI | Up to 24 months post radiation treatment | To evaluate the survival rates of study participants following hippocampal-sparing PCI. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hippocampal-sparing PCI Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Hippocampal-sparing PCI |
|---|---|
| Age, Continuous | 61 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall
The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome.
Time frame: Baseline, 6 months and 12 months post radiation treatment
Population: At the 6 month timepoint, only 17 participants completed the test, and at the 12 month time point only 14 participants took the test.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall | Baseline | 7.45 score on a scale | Standard Deviation 2.64 |
| Hippocampal-sparing PCI | Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall | 6 months | 7.06 score on a scale | Standard Deviation 2.77 |
| Hippocampal-sparing PCI | Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall | 12 months | 7.36 score on a scale | Standard Deviation 2.87 |
Secondary
Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected
Determine whether development of leptomeningeal carcinomatosis following hippocampal-sparing PCI is higher than expected.
Time frame: 6 months, 12 months, 18 months and 24 months post radiation treatment
Population: Data for this outcome measure was not collected.
Secondary
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from not at all to very much. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following: * Dyspnoea * Insomnia * Appetite * Constipation * Diarrhoea * Finances * Fatigue * Nausea/Vomiting * Pain * Physical Function * Role Function * Emotional Function * Cognitive Function * Social Function * Global QoL
Time frame: Baseline and 12 months post radiation treatment
Population: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Dyspnoea | 2.8 score on a scale | Standard Deviation 26.4 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Insomnia | -5.6 score on a scale | Standard Deviation 31.2 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Appetite | -3 score on a scale | Standard Deviation 10 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Constipation | 0 score on a scale | Standard Deviation 47.1 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Diarrhoea | 2.8 score on a scale | Standard Deviation 17.2 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Finances | 2.8 score on a scale | Standard Deviation 22.3 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Fatigue | -0.9 score on a scale | Standard Deviation 21.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Nausea/Vomiting | -1.4 score on a scale | Standard Deviation 26.1 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Pain | 2.8 score on a scale | Standard Deviation 19.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Physical Function | -4.8 score on a scale | Standard Deviation 17.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Role Function | 0 score on a scale | Standard Deviation 22.5 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Emotional Function | 5.6 score on a scale | Standard Deviation 14.8 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Cognitive Function | -9.7 score on a scale | Standard Deviation 20.7 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Social Function | 9.7 score on a scale | Standard Deviation 23 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Global QoL | 2.1 score on a scale | Standard Deviation 15.9 |
Secondary
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following: * Headaches * Seizures * Drowsy * Hair loss * Itching * Weakness * Bladder * Future Uncertainty * Visual Disorder * Motor Dysfunction * Communication Deficit
Time frame: Baseline and 6 months post radiation treatment
Population: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Headaches | 13.3 score on a scale | Standard Deviation 32.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Seizures | -4.4 score on a scale | Standard Deviation 17.2 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Drowsy | 0 score on a scale | Standard Deviation 25.2 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Hair loss | 2.2 score on a scale | Standard Deviation 29.5 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Itching | 6.7 score on a scale | Standard Deviation 28.7 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Weakness | 13.3 score on a scale | Standard Deviation 24.6 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Bladder | 11.1 score on a scale | Standard Deviation 20.6 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Future Uncertainty | 0.6 score on a scale | Standard Deviation 27 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Visual Disorder | 6.3 score on a scale | Standard Deviation 17.3 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Motor Dysfunction | 7.1 score on a scale | Standard Deviation 22.5 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Communication Deficit | 12.7 score on a scale | Standard Deviation 10.5 |
Secondary
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from not at all to very much. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following: * Dyspnoea * Insomnia * Appetite * Constipation * Diarrhoea * Finances * Fatigue * Nausea/Vomiting * Pain * Physical Function * Role Function * Emotional Function * Cognitive Function * Social Function * Global QoL
Time frame: Baseline and 6 months post radiation treatment
Population: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Dyspnoea | 11.1 score on a scale | Standard Deviation 30 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Insomnia | -9.5 score on a scale | Standard Deviation 30.5 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Appetite | 20 score on a scale | Standard Deviation 32.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Constipation | 6.7 score on a scale | Standard Deviation 44 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Diarrhoea | 0 score on a scale | Standard Deviation 12.6 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Finances | 2.4 score on a scale | Standard Deviation 35.7 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Fatigue | 14.1 score on a scale | Standard Deviation 26.4 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Nausea/Vomiting | 3.3 score on a scale | Standard Deviation 25.4 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Pain | 2.2 score on a scale | Standard Deviation 31.4 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Physical Function | -11.6 score on a scale | Standard Deviation 19.8 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Role Function | -4.4 score on a scale | Standard Deviation 23.1 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Emotional Function | 0 score on a scale | Standard Deviation 22 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Cognitive Function | 11.1 score on a scale | Standard Deviation 16.3 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Social Function | 8.9 score on a scale | Standard Deviation 35 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Global QoL | -5.2 score on a scale | Standard Deviation 26.3 |
Secondary
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following: * Headaches * Seizures * Drowsy * Hair loss * Itching * Weakness * Bladder * Future Uncertainty * Visual Disorder * Motor Dysfunction * Communication Deficit Headaches Seizures Drowsy Hair loss Itching Weakness Bladder Future Uncertainty Scale Visual Disorder Scale Motor Dysfunction Scale Communication Deficit Scale
Time frame: Baseline and 12 months post radiation treatment
Population: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Headaches | 9.1 score on a scale | Standard Deviation 33.6 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Seizures | -3 score on a scale | Standard Deviation 10.1 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Drowsy | -6.1 score on a scale | Standard Deviation 29.1 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Hair loss | -15.2 score on a scale | Standard Deviation 22.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Itching | 9.1 score on a scale | Standard Deviation 15.6 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Weakness | 6.1 score on a scale | Standard Deviation 29.1 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Bladder | 12.1 score on a scale | Standard Deviation 30.8 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Future Uncertainty | -3 score on a scale | Standard Deviation 23.9 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Visual Disorder | 3 score on a scale | Standard Deviation 17.3 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Motor Dysfunction | 6.7 score on a scale | Standard Deviation 17.5 |
| Hippocampal-sparing PCI | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Communication Deficit | 6.7 score on a scale | Standard Deviation 11.9 |
Secondary
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A & B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better
Time frame: 12 months post radiation treatment
Population: Data is presented for Hippocampal-sparing PCI (from this study). 14 participants completed the test at 12 months. No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Total Recall | 21.5 score on a scale | Standard Deviation 4.94 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Delayed Recall | 7.36 score on a scale | Standard Deviation 2.87 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Discrimination | 10.6 score on a scale | Standard Deviation 1.22 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Trail Making A | 29.6 score on a scale | Standard Deviation 10.3 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Trail Making B | 101.2 score on a scale | Standard Deviation 72.3 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | COWA | 34.2 score on a scale | Standard Deviation 13.5 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | MMSE | 27.7 score on a scale | Standard Deviation 1.7 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | PCT | 55.6 score on a scale | Standard Deviation 18.8 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BTA | 14.7 score on a scale | Standard Deviation 4.31 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Letter Word Fluency | 25.1 score on a scale | Standard Deviation 8.88 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Category Word Fluency | 42.5 score on a scale | Standard Deviation 7.78 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Verbal Fluency | 66.9 score on a scale | Standard Deviation 14.1 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Total Recall | 19.1 score on a scale | Standard Deviation 6.29 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Delayed Recall | 7.50 score on a scale | Standard Deviation 2.38 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Discrimination | 5.71 score on a scale | Standard Deviation 0.611 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Learning and Memory: Verbal | 92.8 score on a scale | Standard Deviation 17.7 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Learning and Memory: Visual | 94.4 score on a scale | Standard Deviation 17.5 |
Secondary
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A & B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better
Time frame: 6 months post radiation treatment
Population: Data is presented for Hippocampal-sparing PCI (from this study). 14 participants completed the test at 6 months. No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Total Recall | 23.6 score on a scale | Standard Deviation 5.44 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Delayed Recall | 7.06 score on a scale | Standard Deviation 2.77 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Discrimination | 11.1 score on a scale | Standard Deviation 4.76 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Trail Making A | 34.0 score on a scale | Standard Deviation 10.3 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Trail Making B | 101 score on a scale | Standard Deviation 69.5 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | COWA | 31.4 score on a scale | Standard Deviation 13.1 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | MMSE | 27.2 score on a scale | Standard Deviation 2.1 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | PCT | 54.9 score on a scale | Standard Deviation 15 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BTA | 15.1 score on a scale | Standard Deviation 3.22 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Letter Word Fluency | 24.1 score on a scale | Standard Deviation 10.7 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Category Word Fluency | 40.9 score on a scale | Standard Deviation 10.1 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Verbal Fluency | 65.1 score on a scale | Standard Deviation 19.9 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Total Recall | 18.7 score on a scale | Standard Deviation 6.5 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Delayed Recall | 7.64 score on a scale | Standard Deviation 2.28 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Discrimination | 5.64 score on a scale | Standard Deviation 1.08 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Learning and Memory: Verbal | 95.4 score on a scale | Standard Deviation 18 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Learning and Memory: Visual | 96.0 score on a scale | Standard Deviation 16.1 |
Secondary
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A & B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better
Time frame: Baseline
Population: Data is presented for Hippocampal-sparing PCI (from this study). 19 participants completed the test at baseline. No data from standard PCI for comparison to be done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Discrimination | 5.74 score on a scale | Standard Deviation 0.562 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Learning and Memory: Verbal | 93.2 score on a scale | Standard Deviation 15.2 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Learning and Memory: Visual | 96.4 score on a scale | Standard Deviation 23.7 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Total Recall | 23.2 score on a scale | Standard Deviation 3.35 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Delayed Recall | 7.45 score on a scale | Standard Deviation 2.64 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | HVLT-R Discrimination | 10.75 score on a scale | Standard Deviation 1.25 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Trail Making A | 30.1 score on a scale | Standard Deviation 9.79 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Trail Making B | 89.7 score on a scale | Standard Deviation 59 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | COWA | 32.4 score on a scale | Standard Deviation 13.7 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | MMSE | 28.3 score on a scale | Standard Deviation 1.05 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | PCT | 59.1 score on a scale | Standard Deviation 13.7 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BTA | 16.2 score on a scale | Standard Deviation 2.93 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Letter Word Fluency | 25.3 score on a scale | Standard Deviation 7.75 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Category Word Fluency | 44.2 score on a scale | Standard Deviation 8.39 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | CIFA: Verbal Fluency | 68.9 score on a scale | Standard Deviation 12.3 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Total Recall | 19.7 score on a scale | Standard Deviation 7.9 |
| Hippocampal-sparing PCI | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | BVMT-R Delayed Recall | 8.63 score on a scale | Standard Deviation 4.62 |
Secondary
Number Participants With Hippocampus Brain Metastases Following Sparing PCI
The number of participants with brain metastases after sparing PCI treatment was assessed to be compared to two existing studies.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hippocampal-sparing PCI | Number Participants With Hippocampus Brain Metastases Following Sparing PCI | 4 Participants |
Secondary
Percentage of Participants Surviving Following Hippocampal-sparing PCI
To evaluate the survival rates of study participants following hippocampal-sparing PCI.
Time frame: Up to 24 months post radiation treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hippocampal-sparing PCI | Percentage of Participants Surviving Following Hippocampal-sparing PCI | 88 percentage of participants |