Small-cell Lung CancerNCT01797159
Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
A study testing Hippocampal-sparing Prophylactic Cranial Irradiation in people with Small-cell Lung Cancer and SCLC, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Small-cell Lung Cancer, SCLC, Small Cell Lung Cancer Limited Stage
- What is being tested?
- Hippocampal-sparing Prophylactic Cranial Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2013to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bayview Medical Center
Baltimore, Maryland, 21227
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: "A Phase II Trial of Hippocampal-Sparing Cranial Irradiation (PCI) for Small-Cell Lung Cancer (SCLC)"
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.
Read the 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.
- Being tested
- Hippocampal-sparing Prophylactic Cranial Irradiation
- Keywords
- Prophylactic Cranial Irradiation, PCI, Hippocampal-sparing irradiation
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hippocampal-sparing Prophylactic Cranial IrradiationRadiation
Hippocampal-sparing Prophylactic Cranial Irradiation
| Study group | Role | What they receive |
|---|---|---|
| Hippocampal-sparing PCI | Experimental | Hippocampal-sparing PCI 25 Gy in 10 fractions Receives: Radiation: Hippocampal-sparing Prophylactic Cranial Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months and 12 months post radiation treatment
Secondary outcomes (10)
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
Measured: Baseline
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
Measured: 6 months post radiation treatment
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
Measured: 12 months post radiation treatment
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
Measured: Baseline and 6 months post radiation treatment
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
Measured: Baseline and 12 months post radiation treatment
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
Measured: Baseline and 6 months post radiation treatment
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
Measured: Baseline and 12 months post radiation treatment
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.
Measured: 12 months
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.
Measured: 6 months, 12 months, 18 months and 24 months post radiation treatment
Percentage of Participants Surviving Following Hippocampal-sparing PCI
To evaluate the survival rates of study participants following hippocampal-sparing PCI.
Measured: Up to 24 months post radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study start11 Mar 2013
- Primary completion18 Mar 2018
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Redmond, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797159
- Sponsor's protocol ID
- J12127
- Other IDs
- NA_00078659
- Status last verified
- Sep 2021
- First submitted
- 30 Nov 2012
- Last updated
- 18 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to share data with PIs who are not included on the study team.
Publications
Redmond KJ, Hales RK, Anderson-Keightly H, Zhou XC, Kummerlowe M, Sair HI, Duhon M, Kleinberg L, Rosner GL, Vannorsdall T. Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):603-611. doi: 10.1016/j.ijrobp.2017.03.009. Epub 2017 Mar 14.
PubMed 28581401
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Phase II Trial of Hippocampal-Sparing Cranial Irradiation (PCI) for Small-Cell Lung Cancer (SCLC)"
- ClinicalTrials.gov ID
- NCT01797159
- Acronym / sponsor ID
- J12127
- Keywords
- Prophylactic Cranial Irradiation, PCI, Hippocampal-sparing irradiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hippocampal-sparing PCI | Experimental | Radiation: Hippocampal-sparing Prophylactic Cranial IrradiationHippocampal-sparing PCI 25 Gy in 10 fractions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hippocampal-sparing Prophylactic Cranial IrradiationHippocampal-sparing Prophylactic Cranial Irradiation | Radiation | Hippocampal-sparing PCI |
Primary outcome
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
Time frame: 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.
10 secondary outcomes
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Time frame: Baseline
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Time frame: 6 months post radiation treatment
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Time frame: 12 months post radiation treatment
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Time frame: Baseline and 6 months post radiation treatment
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Time frame: Baseline and 12 months post radiation treatment
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Time frame: Baseline and 6 months post radiation treatment
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).
Time frame: Baseline and 12 months post radiation treatment
Number Participants With Hippocampus Brain Metastases Following Sparing PCI
Time frame: 12 months
Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected
Time frame: 6 months, 12 months, 18 months and 24 months post radiation treatment
Percentage of Participants Surviving Following Hippocampal-sparing PCI
Time frame: Up to 24 months post radiation treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28581401Redmond KJ, Hales RK, Anderson-Keightly H, Zhou XC, Kummerlowe M, Sair HI, Duhon M, Kleinberg L, Rosner GL, Vannorsdall T. Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):603-611. doi: 10.1016/j.ijrobp.2017.03.009. Epub 2017 Mar 14.
- Individual participant dataSharing planned: No. There is no plan to share data with PIs who are not included on the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Redmond, M.D. principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippocampal-sparing Prophylactic Cranial Irradiation in people with Small-cell Lung Cancer and SCLC, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, 6 months and 12 months post radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.