Small Cell Lung CancerPhase 2NCT02906384
Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)
A Phase 2 study testing hippocampus avoidance in people with Small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- hippocampus avoidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically conformed small cell lung cancer;
- Complete response (CR)/partial response (PR) after chemo-radiotherapy;
- ECOG (Eastern Cooperative Oncology Group) : 0-1;
- No imaging evidence of brain metastasis before PCI;
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
- Able to understand this study and have signed informed consent.
Who cannot join
- Unable to receive MRI;
- Medical history of central nervous system, cognitive or psychological diseases;
- The expectation of life is less than 6 months;
- Female in pregnancy or lactating;
- The researchers consider the patient not appropriate to be enrolled.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ming Chen, PHD, chenming@zjcc.org.cn
Ming Chen, PHD
About this study
Official title: Memory Preservation and Functional Brain Magnetic Resonance Imaging Changes With Conformal Avoidance of the Hippocampal Neural Stem-cell Compartment During Prophylactic Cranial Irradiation for Small Cell Lung Cancer Patients: A Prospective, Randomized Phase-II Study
This is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients.
Read the detailed description
Brain metastasis is rather high in small cell lung cancer patients. Prophylactic cranial irradiation(PCI) is the standardized treatment. However, cognitive dysfunction like memory damage is observed in quite a number of patients after brain irradiation, which may due to the hippocampus being irradiated. Thus, the investigators conduct the study by reducing the dose to the hippocampal neural stem-cell compartment (HAZ) during PCI.
Patient Population: Age: 18-65y; small cell lung cancer undergoing PCI; Eastern Cooperative Oncology Group (ECOG) score: 0-1.
The patients are randomized to 2 arms:
Arm Routine PCI: PTV(planning target volume) 25Gy/10F. Arm Hippocampus avoidance PCI(HA-PCI): PTV 25Gray(Gy)/10Fraction(F), HAZ Dmin<9Gy Dmax<16Gy).
Measurements: Hopkins verbal learning test(HVLT) and functional brain magnetic resonance imaging.
- Conditions
- Small Cell Lung Cancer
- Being tested
- hippocampus avoidance
- Keywords
- hippocampus avoidance, volumetric modulated arc therapy, functional MRI, hopkins Verbal Learning Test, prophylactic cranial 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.
hippocampus avoidanceRadiation
conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation
| Study group | Role | What they receive |
|---|---|---|
| routine PCI | No intervention | PTV:25Gy/10F. Radiation technique: VMAT. |
| HA-PCI | Experimental | PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy.
Radiation technique: VMAT. Receives: Radiation: hippocampus avoidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory preservation
responses to Hopkins Verbal Learning Test
Measured: 2 years
Secondary outcomes (3)
overall survival
Overall survival will be evaluated
Measured: 2 years
hippocampus metastasis
hippocampus metastasis rate will be recorded
Measured: 2 years
image changes of brain
changes of functional brain MRI will be recorded.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Chen, PHD, Principal investigator, Zhejiang Cancer HospitalYue Kong, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906384
- Sponsor's protocol ID
- ZJCH-HA-PCI
- Status last verified
- Oct 2016
- First submitted
- 9 Sep 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Preservation and Functional Brain Magnetic Resonance Imaging Changes With Conformal Avoidance of the Hippocampal Neural Stem-cell Compartment During Prophylactic Cranial Irradiation for Small Cell Lung Cancer Patients: A Prospective, Randomized Phase-II Study
- ClinicalTrials.gov ID
- NCT02906384
- Acronym / sponsor ID
- ZJCH-HA-PCI
- Conditions
- Small Cell Lung Cancer
- Keywords
- hippocampus avoidance, volumetric modulated arc therapy, functional MRI, hopkins Verbal Learning Test, prophylactic cranial irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- 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 is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients.
Detailed description
Brain metastasis is rather high in small cell lung cancer patients. Prophylactic cranial irradiation(PCI) is the standardized treatment. However, cognitive dysfunction like memory damage is observed in quite a number of patients after brain irradiation, which may due to the hippocampus being irradiated. Thus, the investigators conduct the study by reducing the dose to the hippocampal neural stem-cell compartment (HAZ) during PCI.
Patient Population: Age: 18-65y; small cell lung cancer undergoing PCI; Eastern Cooperative Oncology Group (ECOG) score: 0-1.
The patients are randomized to 2 arms:
Arm Routine PCI: PTV(planning target volume) 25Gy/10F. Arm Hippocampus avoidance PCI(HA-PCI): PTV 25Gray(Gy)/10Fraction(F), HAZ Dmin<9Gy Dmax<16Gy).
Measurements: Hopkins verbal learning test(HVLT) and functional brain magnetic resonance imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine PCI | No intervention | –PTV:25Gy/10F. Radiation technique: VMAT. |
| HA-PCI | Experimental | Radiation: hippocampus avoidancePTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy. Radiation technique: VMAT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically conformed small cell lung cancer;
- Complete response (CR)/partial response (PR) after chemo-radiotherapy;
- ECOG (Eastern Cooperative Oncology Group) : 0-1;
- No imaging evidence of brain metastasis before PCI;
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
Key exclusion criteria (5 listed)
- Unable to receive MRI;
- Medical history of central nervous system, cognitive or psychological diseases;
- The expectation of life is less than 6 months;
- Female in pregnancy or lactating;
- The researchers consider the patient not appropriate to be enrolled.
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 |
|---|---|---|
| hippocampus avoidanceconformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation | Radiation | HA-PCI |
Primary outcome
memory preservation
Time frame: 2 years
responses to Hopkins Verbal Learning Test
3 secondary outcomes
overall survival
Time frame: 2 years
hippocampus metastasis
Time frame: 2 years
image changes of brain
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- 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.
Ming Chen, PHD principal investigator
Zhejiang Cancer Hospital
Yue Kong principal investigator
Zhejiang Cancer Hospital
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 hippocampus avoidance in people with Small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
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 6 inclusion and 5 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 10 Oct 2016. 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 China. 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 Ming Chen, PHD (0086-571-88122068, chenming@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
memory preservation (time frame: 2 years). 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 10 Oct 2016; AzTrials last refreshed its copy on 28 Oct 2026.