Small Cell Lung CancerPhase 3HA-PCINCT01780675
Hippocampus Avoidance PCI vs PCI
A Phase 3 study testing Radiation Prophylactic Cranial Irradiation and Radiation Hippocampal Avoidance PCI in people with Small Cell Lung Cancer and Lung Cancer, run by The Netherlands Cancer Institute at 9 sites in 2 countries.
Trial summary
Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- Radiation Prophylactic Cranial Irradiation and Radiation Hippocampal Avoidance PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2013to Jan 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Small Cell Lung Cancer patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV
- Sufficient proficiency in Dutch
Who cannot join
- Prior radiotherapy to the brain
- Clinical evidence for brain metastases or primary brain tumors- Evidence of progressive extracranial metastatic disease
- Previous malignancy < 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- Any systemic anticancer treatment during PCI or within 3 weeks before start PCI
- Pregnancy or lactation
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Netherlands6 sites
The Netherlands Cancer Institute
Amsterdam, 1066CX
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Catharina Ziekenhuis
Eindhoven, 5623EJ
Universitair Medisch Centrum Groningen
Groningen, 9700RB
Erasmus MC Cancer Centre
Rotterdam, 3075 EA
Instituut Verbeeten
Tilburg, 5042 SB
Belgium3 sites
Universitair Ziekenhuis Antwerpen
Antwerp, B-2650
Universitair Ziekenhuis Gent
Ghent, B-9000
Universitair Ziekenhuis Leuven
Leuven, B-3000
About this study
Official title: Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet.
This study is initiated to investigate the early and delayed neurotoxicity of PCI and to assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell Lung Cancer patients who receive PCI.
- Conditions
- Small Cell Lung Cancer, Lung Cancer
- Being tested
- Radiation Prophylactic Cranial Irradiation, Radiation Hippocampal Avoidance PCI
- Keywords
- Prophylactic Cranial Irradiation, Hippocampal Avoidance Prophylactic Cranial Irradiation
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Prophylactic Cranial IrradiationRadiation
Radiation Hippocampal Avoidance PCIRadiation
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Cranial Irradiation | Active comparator | Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy) Receives: Radiation: Radiation Prophylactic Cranial Irradiation |
| Hippocampal Avoidance PCI | Experimental | Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy). Receives: Radiation: Radiation Hippocampal Avoidance PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognitive decline
Each patient's total recall score recorded at 4 months will be compared to baseline and dichotomized into success (decline less or equal 5 points) or failure (decline more than 5 points). The difference between the groups, in terms of dichotomized decline will be tested by means of the Fisher's exact test. A p-value less than 0.049 will be considered significant. The primary analysis will be based on an intention-to-treat principle.
Measured: 4 months
Secondary outcomes (1)
safety
Brain metastases Time from randomization to the occurrence of brain metastases will be calculated and depicted in a cumulative incidence plot. Sensitivity analysis will be performed to assess the value of PCI vs HA-PCI treatment once considering patients dying without distant brain metastases to be censored and once using competing risk analysis considering distant metastases and death as separate events
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 posted31 Jan 2013 (estimated)
- Study startApr 2013
- Primary completion1 Apr 2019
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Jose Belderbos, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780675
- Sponsor's protocol ID
- M12PHA
- Acronym
- HA-PCI
- Status last verified
- Jan 2022
- First submitted
- 29 Jan 2013
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Zeng H, Schagen SB, Hendriks LEL, Sanchez-Benavides G, Jaspers JPM, Manero RM, Lievens Y, Murcia-Mejia M, Kuenen M, Rico-Oses M, Albers EAC, Samper P, Houben R, de Ruiter MB, Dieleman EMT, Lopez-Guerra JL, De Jaeger K, Counago F, Lambrecht M, Calvo-Crespo P, Belderbos JSA, De Ruysscher DKM, Rodriguez de Dios N. Impact of HA-PCI on self-reported cognitive functioning and brain metastases in small-cell lung cancer: Pooled findings of NCT01780675 and PREMER trials. Lung Cancer. 2025 Jan;199:108036. doi: 10.1016/j.lungcan.2024.108036. Epub 2024 Nov 23.
PubMed 39615412Ishibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497.
PubMed 34632876
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT01780675
- Acronym / sponsor ID
- HA-PCI / M12PHA
- Conditions
- Small Cell Lung Cancer, Lung Cancer
- Keywords
- Prophylactic Cranial Irradiation, Hippocampal Avoidance Prophylactic Cranial Irradiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Apr 2013
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 31 Jan 2013 (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.
Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet.
This study is initiated to investigate the early and delayed neurotoxicity of PCI and to assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell Lung Cancer patients who receive PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Cranial Irradiation | Active comparator | Radiation: Radiation Prophylactic Cranial IrradiationRadiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy) |
| Hippocampal Avoidance PCI | Experimental | Radiation: Radiation Hippocampal Avoidance PCIRadiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Small Cell Lung Cancer patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV
- Sufficient proficiency in Dutch
Key exclusion criteria (5 listed)
- Prior radiotherapy to the brain
- Clinical evidence for brain metastases or primary brain tumors- Evidence of progressive extracranial metastatic disease
- Previous malignancy < 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- Any systemic anticancer treatment during PCI or within 3 weeks before start PCI
- Pregnancy or lactation
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 |
|---|---|---|
| Radiation Prophylactic Cranial Irradiation | Radiation | Prophylactic Cranial Irradiation |
| Radiation Hippocampal Avoidance PCI | Radiation | Hippocampal Avoidance PCI |
Primary outcome
neurocognitive decline
Time frame: 4 months
Each patient's total recall score recorded at 4 months will be compared to baseline and dichotomized into success (decline less or equal 5 points) or failure (decline more than 5 points). The difference between the groups, in terms of dichotomized decline will be tested by means of the Fisher's exact test. A p-value less than 0.049 will be considered significant. The primary analysis will be based on an intention-to-treat principle.
1 secondary outcome
safety
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 39615412Zeng H, Schagen SB, Hendriks LEL, Sanchez-Benavides G, Jaspers JPM, Manero RM, Lievens Y, Murcia-Mejia M, Kuenen M, Rico-Oses M, Albers EAC, Samper P, Houben R, de Ruiter MB, Dieleman EMT, Lopez-Guerra JL, De Jaeger K, Counago F, Lambrecht M, Calvo-Crespo P, Belderbos JSA, De Ruysscher DKM, Rodriguez de Dios N. Impact of HA-PCI on self-reported cognitive functioning and brain metastases in small-cell lung cancer: Pooled findings of NCT01780675 and PREMER trials. Lung Cancer. 2025 Jan;199:108036. doi: 10.1016/j.lungcan.2024.108036. Epub 2024 Nov 23.
- Derived from this study: PubMed 34632876Ishibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497.
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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.
Jose Belderbos, MD, PhD principal investigator
The Netherlands Cancer Institute
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation Prophylactic Cranial Irradiation and Radiation Hippocampal Avoidance PCI in people with Small Cell Lung Cancer and Lung Cancer, run by The Netherlands Cancer Institute at 9 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
neurocognitive decline (time frame: 4 months). 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 NCT01780675, which also lists 2 linked publications.
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 21 Jan 2022.