Carcinoma, Small Cell LungNCT02736916
HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
A study testing HS-WBRT PCI and Conventional PCI in people with Carcinoma, Small Cell Lung, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several side effects, such as decline in memory and other cognitive functions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Small Cell Lung
- What is being tested?
- HS-WBRT PCI and Conventional PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- 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 80 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 CR (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 CXR (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Jie Wei, M.D., 86-951-6744528, nyfykyc@163.com
About this study
Official title: Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several side effects, such as decline in memory and other cognitive functions. This provides the rationale to explore the clinical feasibility of hippocampal avoidance during WBRT. Previous studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the hippocampus without detriment to the radiation dose the remaining brain receives. The aims of this study is to evaluate the therapy efficacy and the safety profile of hippocampal-sparing whole-brain radiation therapy (HS-WBRT) for PCI in patients with LD-SCLC.
Read the detailed description
Chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) is the standard of care in management of limited stage small cell lung cancer patients. However, whole brain radiation therapy (WBRT) is also associated with many side effects including consolidation of new memory, poor attention span/concentration, visual spatial difficulties, difficulty with executive planning, and poor fine motor control. There exists significant preclinical and clinical evidence that radiation induced injury to the hippocampus correlates with neurocognitive decline of patients who received WBRT. Reducing radiation dose to the hippocampus during WBRT has been postulated as an approach to mitigate neurocognitive impairment. The present study hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control 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: composite cognitive function following hippocampal-sparing PCI relative to the historical control and the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI.
- Conditions
- Carcinoma, Small Cell Lung
- Being tested
- HS-WBRT PCI, Conventional PCI
- 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.
HS-WBRT PCIRadiation
LD-SCLC patients with HS-WBRT PCI
Conventional PCIRadiation
LD-SCLC patients with conventional PCI
| Study group | Role | What they receive |
|---|---|---|
| HS-WBRT PCI | Experimental | LD-SCLC patients with HS-WBRT PCI Receives: Radiation: HS-WBRT PCI |
| Conventional PCI | Active comparator | LD-SCLC patients with Conventional PCI Receives: Radiation: Conventional PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal sparing during whole-brain radiotherapy (HS-WBRT) for PCI of limited stage small cell lung cancer patients.
Measured: The change of the performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 4 months following hippocampal-sparing PCI relative to the control group
Secondary outcomes (1)
Evaluate the rate of brain metastasis in hippocampal region after HS-WBRT PCI for limited stage small cell lung cancer patients.
Measured: The metastatic rate between HS-WBRT and control group at 2 years following hippocampal-sparing PCI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small Cell LungStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ren Zhao, M.D., Study chair, General Hospital of Ningxia Medical Universuty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736916
- Sponsor's protocol ID
- Radiation Oncology 20160101
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2016
- Last updated
- 13 Apr 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 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02736916
- Acronym / sponsor ID
- Radiation Oncology 20160101
- Conditions
- Carcinoma, Small Cell Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Apr 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.
Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several side effects, such as decline in memory and other cognitive functions. This provides the rationale to explore the clinical feasibility of hippocampal avoidance during WBRT. Previous studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the hippocampus without detriment to the radiation dose the remaining brain receives. The aims of this study is to evaluate the therapy efficacy and the safety profile of hippocampal-sparing whole-brain radiation therapy (HS-WBRT) for PCI in patients with LD-SCLC.
Detailed description
Chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) is the standard of care in management of limited stage small cell lung cancer patients. However, whole brain radiation therapy (WBRT) is also associated with many side effects including consolidation of new memory, poor attention span/concentration, visual spatial difficulties, difficulty with executive planning, and poor fine motor control. There exists significant preclinical and clinical evidence that radiation induced injury to the hippocampus correlates with neurocognitive decline of patients who received WBRT. Reducing radiation dose to the hippocampus during WBRT has been postulated as an approach to mitigate neurocognitive impairment. The present study hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control 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: composite cognitive function following hippocampal-sparing PCI relative to the historical control and the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-WBRT PCI | Experimental | Radiation: HS-WBRT PCILD-SCLC patients with HS-WBRT PCI |
| Conventional PCI | Active comparator | Radiation: Conventional PCILD-SCLC patients with Conventional PCI |
Who may qualify
- Ages
- 18 to 80 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 CR (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 (6 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 CXR (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 |
|---|---|---|
| HS-WBRT PCILD-SCLC patients with HS-WBRT PCI | Radiation | HS-WBRT PCI |
| Conventional PCILD-SCLC patients with conventional PCI | Radiation | Conventional PCI |
Primary outcome
Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal sparing during whole-brain radiotherapy (HS-WBRT) for PCI of limited stage small cell lung cancer patients.
Time frame: The change of the performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 4 months following hippocampal-sparing PCI relative to the control group
1 secondary outcome
Evaluate the rate of brain metastasis in hippocampal region after HS-WBRT PCI for limited stage small cell lung cancer patients.
Time frame: The metastatic rate between HS-WBRT and control group at 2 years following hippocampal-sparing PCI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
Ren Zhao, M.D. study chair
General Hospital of Ningxia Medical Universuty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-WBRT PCI and Conventional PCI in people with Carcinoma, Small Cell Lung, run by General Hospital of Ningxia Medical University 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 8 inclusion and 6 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 13 Apr 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.
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 Yan-Yang Wang, M.D. (86-951-6743315, fdwyy1981@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal sparing during whole-brain radiotherapy (HS-WBRT) for PCI of limited stage small cell lung cancer patients. (time frame: The change of the performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 4 months following hippocampal-sparing PCI relative to the control group). 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 13 Apr 2016.