Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Completed
CT.gov ID
NCT01797159
Collaborator
(none)
20
2
1
72.2
10
0.1

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
  • Radiation: Hippocampal-sparing Prophylactic Cranial Irradiation
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

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"A Phase II Trial of Hippocampal-Sparing Cranial Irradiation (PCI) for Small-Cell Lung Cancer (SCLC)"
Actual Study Start Date :
Mar 11, 2013
Actual Primary Completion Date :
Mar 18, 2018
Actual Study Completion Date :
Mar 18, 2019

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

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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.

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.
Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT01797159
Other Study ID Numbers:
  • J12127
  • NA_00078659
First Posted:
Feb 22, 2013
Last Update Posted:
Oct 18, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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)
3. Secondary Outcome
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)
4. Secondary Outcome
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)
5. Secondary Outcome
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)
6. Secondary Outcome
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)
7. Secondary Outcome
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)
8. Secondary Outcome
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)
9. Secondary Outcome
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%
10. Secondary Outcome
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
11. Secondary Outcome
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

[Not Specified]

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
Email kjansen3@jhmi.edu
Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT01797159
Other Study ID Numbers:
  • J12127
  • NA_00078659
First Posted:
Feb 22, 2013
Last Update Posted:
Oct 18, 2021
Last Verified:
Sep 1, 2021