Brain MetastasesPhase 2KROG17-06NCT03366376
Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC
A Phase 2 study testing WBRT with hippocampus-sparing and SIB in people with Brain Metastases, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- WBRT with hippocampus-sparing and SIB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2017to 1 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven diagnosis of primary non-small cell lung cancer
- 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration
- KPS ≥70
- Age ≥55 years
- Informed consent prior to study entry
Who cannot join
- Patients with leptomeningeal metastases
- ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months
- Contraindication to MRI such as implanted metal devices or foreign bodies
- Prior radiation therapy (including SRS) to the brain
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Yong Chan Ahn, MD,PhD, +82-2-3410-2602, ycahn.ahn@samsung.com
Jae Myoung Noh, MD,PhD
About this study
Official title: A Phase II Multi-institutional Study of Hippocampus-sparing Whole Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases From Non-small Cell Lung Cancer
This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.
- Conditions
- Brain Metastases
- Being tested
- WBRT with hippocampus-sparing and SIB
- Keywords
- hippocampus, radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBRT with hippocampus-sparing and SIBRadiation
Radiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below;
Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | WBRT with hippocampus-sparing and SIB Receives: Radiation: WBRT with hippocampus-sparing and SIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial progression free survival
Time from the date of start of radiotherapy to the date of death or intracranial progression
Measured: until 12 months
Secondary outcomes (4)
Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)
The relative decline in SVLT-E score from baseline to below time frame; ΔSVLT = (SVLTB - SVLTF) ÷ SVLTB, where B=baseline and F=follow-up.
Measured: 3,6,12 months
Overall survival
Time from the date of start of radiotherapy to the date of death from any cause
Measured: until 12 months
Adverse events
CTCAE v4.03
Measured: 3,6,12 months
Quality of life
EORTC QLQ-C30 and BN20
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start11 Dec 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Radiation Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366376
- Sponsor's protocol ID
- 2017-08-070
- Acronym
- KROG17-06
- Status last verified
- Dec 2017
- First submitted
- 3 Dec 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-institutional Study of Hippocampus-sparing Whole Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases From Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03366376
- Acronym / sponsor ID
- KROG17-06 / 2017-08-070
- Conditions
- Brain Metastases
- Keywords
- hippocampus, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korean Radiation Oncology Group
- Study start
- 11 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: WBRT with hippocampus-sparing and SIBWBRT with hippocampus-sparing and SIB |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically proven diagnosis of primary non-small cell lung cancer
- 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration
- KPS ≥70
- Age ≥55 years
- Informed consent prior to study entry
Key exclusion criteria (4 listed)
- Patients with leptomeningeal metastases
- ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months
- Contraindication to MRI such as implanted metal devices or foreign bodies
- Prior radiation therapy (including SRS) to the brain
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 |
|---|---|---|
| WBRT with hippocampus-sparing and SIBRadiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below; Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy | Radiation | Experimental |
Primary outcome
Intracranial progression free survival
Time frame: until 12 months
Time from the date of start of radiotherapy to the date of death or intracranial progression
4 secondary outcomes
Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)
Time frame: 3,6,12 months
Overall survival
Time frame: until 12 months
Adverse events
Time frame: 3,6,12 months
Quality of life
Time frame: 3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WBRT with hippocampus-sparing and SIB in people with Brain Metastases, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Chan Ahn, MD, PhD (+82-2-3410-2602, ycahn.ahn@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial progression free survival (time frame: until 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2017.