Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Hippocampal-sparing PCI Hippocampal-sparing PCI 25 Gy in 10 fractions |
Radiation: Hippocampal-sparing Prophylactic Cranial Irradiation
Hippocampal-sparing Prophylactic Cranial Irradiation
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Cognitive Function Following Sparing PCI to That of Standard PCI [6 months post radiation treatment]
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 Cognitive Function Following Sparing PCI to That of Standard PCI [12 months post radiation treatment]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bayview Medical Center | Baltimore | Maryland | United States | 21227 |
2 | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
- Principal Investigator: Kristin Redmond, M.D., Johns Hopkins University
Study Documents (Full-Text)
More Information
Publications
None provided.- J12127
- NA_00078659
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Period Title: Overall Study | |
STARTED | 20 |
COMPLETED | 20 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation |
Overall Participants | 20 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
61
|
Sex: Female, Male (Count of Participants) | |
Female |
12
60%
|
Male |
8
40%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
20
100%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (Count of Participants) | |
United States |
20
100%
|
Outcome Measures
Title | 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 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation |
Measure Participants | 20 |
Baseline |
7.45
(2.64)
|
6 months |
7.06
(2.77)
|
12 months |
7.36
(2.87)
|
Title | Compare Cognitive Function Following Sparing PCI to That of Standard PCI |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation |
Measure Participants | 19 |
HVLT-R Total Recall |
23.2
(3.35)
|
HVLT-R Delayed Recall |
7.45
(2.64)
|
HVLT-R Discrimination |
10.75
(1.25)
|
Trail Making A |
30.1
(9.79)
|
Trail Making B |
89.7
(59)
|
COWA |
32.4
(13.7)
|
MMSE |
28.3
(1.05)
|
PCT |
59.1
(13.7)
|
BTA |
16.2
(2.93)
|
CIFA: Letter Word Fluency |
25.3
(7.75)
|
CIFA: Category Word Fluency |
44.2
(8.39)
|
CIFA: Verbal Fluency |
68.9
(12.3)
|
BVMT-R Total Recall |
19.7
(7.9)
|
BVMT-R Delayed Recall |
8.63
(4.62)
|
BVMT-R Discrimination |
5.74
(.562)
|
Learning and Memory: Verbal |
93.2
(15.2)
|
Learning and Memory: Visual |
96.4
(23.7)
|
Title | Compare Cognitive Function Following Sparing PCI to That of Standard PCI |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation |
Measure Participants | 14 |
HVLT-R Total Recall |
23.6
(5.44)
|
HVLT-R Delayed Recall |
7.06
(2.77)
|
HVLT-R Discrimination |
11.1
(4.76)
|
Trail Making A |
34.0
(10.3)
|
Trail Making B |
101
(69.5)
|
COWA |
31.4
(13.1)
|
MMSE |
27.2
(2.10)
|
PCT |
54.9
(15)
|
BTA |
15.1
(3.22)
|
CIFA: Letter Word Fluency |
24.1
(10.7)
|
CIFA: Category Word Fluency |
40.9
(10.1)
|
CIFA: Verbal Fluency |
65.1
(19.9)
|
BVMT-R Total Recall |
18.7
(6.5)
|
BVMT-R Delayed Recall |
7.64
(2.28)
|
BVMT-R Discrimination |
5.64
(1.08)
|
Learning and Memory: Verbal |
95.4
(18)
|
Learning and Memory: Visual |
96.0
(16.1)
|
Title | Compare Cognitive Function Following Sparing PCI to That of Standard PCI |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation |
Measure Participants | 14 |
HVLT-R Total Recall |
21.5
(4.94)
|
HVLT-R Delayed Recall |
7.36
(2.87)
|
HVLT-R Discrimination |
10.6
(1.22)
|
Trail Making A |
29.6
(10.3)
|
Trail Making B |
101.2
(72.3)
|
COWA |
34.2
(13.5)
|
MMSE |
27.7
(1.7)
|
PCT |
55.6
(18.8)
|
BTA |
14.7
(4.31)
|
CIFA: Letter Word Fluency |
25.1
(8.88)
|
CIFA: Category Word Fluency |
42.5
(7.78)
|
CIFA: Verbal Fluency |
66.9
(14.1)
|
BVMT-R Total Recall |
19.1
(6.29)
|
BVMT-R Delayed Recall |
7.50
(2.38)
|
BVMT-R Discrimination |
5.71
(0.611)
|
Learning and Memory: Verbal |
92.8
(17.7)
|
Learning and Memory: Visual |
94.4
(17.5)
|
Title | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 20 |
Dyspnoea |
11.1
(30)
|
Insomnia |
-9.5
(30.5)
|
Appetite |
20
(32.9)
|
Constipation |
6.7
(44)
|
Diarrhoea |
0
(12.6)
|
Finances |
2.4
(35.7)
|
Fatigue |
14.1
(26.4)
|
Nausea/Vomiting |
3.3
(25.4)
|
Pain |
2.2
(31.4)
|
Physical Function |
-11.6
(19.8)
|
Role Function |
-4.4
(23.1)
|
Emotional Function |
0
(22)
|
Cognitive Function |
11.1
(16.3)
|
Social Function |
8.9
(35)
|
Global QoL |
-5.2
(26.3)
|
Title | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 20 |
Dyspnoea |
2.8
(26.4)
|
Insomnia |
-5.6
(31.2)
|
Appetite |
-3
(10)
|
Constipation |
0
(47.1)
|
Diarrhoea |
2.8
(17.2)
|
Finances |
2.8
(22.3)
|
Fatigue |
-0.9
(21.9)
|
Nausea/Vomiting |
-1.4
(26.1)
|
Pain |
2.8
(19.9)
|
Physical Function |
-4.8
(17.9)
|
Role Function |
0
(22.5)
|
Emotional Function |
5.6
(14.8)
|
Cognitive Function |
-9.7
(20.7)
|
Social Function |
9.7
(23)
|
Global QoL |
2.1
(15.9)
|
Title | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 20 |
Headaches |
13.3
(32.9)
|
Seizures |
-4.4
(17.2)
|
Drowsy |
0
(25.2)
|
Hair loss |
2.2
(29.5)
|
Itching |
6.7
(28.7)
|
Weakness |
13.3
(24.6)
|
Bladder |
11.1
(20.6)
|
Future Uncertainty |
0.6
(27)
|
Visual Disorder |
6.3
(17.3)
|
Motor Dysfunction |
7.1
(22.5)
|
Communication Deficit |
12.7
(10.5)
|
Title | 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). |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 20 |
Headaches |
9.1
(33.6)
|
Seizures |
-3
(10.1)
|
Drowsy |
-6.1
(29.1)
|
Hair loss |
-15.2
(22.9)
|
Itching |
9.1
(15.6)
|
Weakness |
6.1
(29.1)
|
Bladder |
12.1
(30.8)
|
Future Uncertainty |
-3
(23.9)
|
Visual Disorder |
3
(17.3)
|
Motor Dysfunction |
6.7
(17.5)
|
Communication Deficit |
6.7
(11.9)
|
Title | Number Participants With Hippocampus Brain Metastases Following Sparing PCI |
---|---|
Description | The number of participants with brain metastases after sparing PCI treatment was assessed to be compared to two existing studies. |
Time Frame | 12 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 20 |
Count of Participants [Participants] |
4
20%
|
Title | Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Data for this outcome measure was not collected. |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 0 |
Title | Percentage of Participants Surviving Following Hippocampal-sparing PCI |
---|---|
Description | To evaluate the survival rates of study participants following hippocampal-sparing PCI. |
Time Frame | Up to 24 months post radiation treatment |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Hippocampal-sparing PCI |
---|---|
Arm/Group Description | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
Measure Participants | 20 |
Number (95% Confidence Interval) [percentage of participants] |
88
440%
|
Adverse Events
Time Frame | Adverse events were followed for a one-year period. | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Hippocampal-sparing PCI | |
Arm/Group Description | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation | |
All Cause Mortality |
||
Hippocampal-sparing PCI | ||
Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | |
Serious Adverse Events |
||
Hippocampal-sparing PCI | ||
Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Hippocampal-sparing PCI | ||
Affected / at Risk (%) | # Events | |
Total | 20/20 (100%) | |
Ear and labyrinth disorders | ||
Tinnitus | 7/20 (35%) | |
Hearing Changes | 3/20 (15%) | |
Eye disorders | ||
Ocular Visual | 3/20 (15%) | |
Gastrointestinal disorders | ||
Nausea | 7/20 (35%) | |
Constipation | 6/20 (30%) | |
Vomit | 5/20 (25%) | |
Dyspepsia | 11/20 (55%) | |
General disorders | ||
Fatigue | 18/20 (90%) | |
Alopecia | 14/20 (70%) | |
Dysphagia | 9/20 (45%) | |
Anorexia | 7/20 (35%) | |
Memory Loss | 7/20 (35%) | |
Insomnia | 11/20 (55%) | |
Taste Disturbance | 6/20 (30%) | |
Mucus | 6/20 (30%) | |
Dizziness/lightheaded | 5/20 (25%) | |
Dysgeusia | 3/20 (15%) | |
Headache | 3/20 (15%) | |
Hot Flash | 2/20 (10%) | |
Voice changes | 2/20 (10%) | |
Pain | 8/20 (40%) | |
Nervous system disorders | ||
Neuropathy | 3/20 (15%) | |
Aphasia | 2/20 (10%) | |
Psychiatric disorders | ||
Personality Behavioral | 4/20 (20%) | |
Renal and urinary disorders | ||
Urinary Incontinence | 2/20 (10%) | |
Respiratory, thoracic and mediastinal disorders | ||
cough | 15/20 (75%) | |
Dsypnea | 11/20 (55%) | |
Pharynx and esophogus | 4/20 (20%) | |
Skin and subcutaneous tissue disorders | ||
Skin | 6/20 (30%) | |
Dermatitis | 6/20 (30%) | |
Surgical and medical procedures | ||
Pain due to radiation therapy | 6/20 (30%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | The SKCCC at Johns Hopkins |
---|---|
Organization | The SKCCC at Johns Hopkins |
Phone | 4109556980 |
kjansen3@jhmi.edu |
- J12127
- NA_00078659