AzTrials
AzTrials

Small Cell Lung CarcinomaNCT02397733

Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)

A study testing Prophylactic cranial irradiation (PCI) and Hippocampal avoidance PCI in people with Small Cell Lung Carcinoma, run by Grupo de Investigación Clínica en Oncología Radioterapia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Prophylactic cranial irradiation (PCI) and Hippocampal avoidance PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSpain
Study dates
Sep 2014to Dec 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • New diagnosed cytological or histologically confirmed Small cell lung carcinoma (stage I-IV) candidate for PCI, for example, without progressive disease after chemo-radiotherapy in stage I-III or after response after chemotherapy in stage IV
  • Performance status ≤ 1
  • Negative MRI of the brain within one month before protocol entry
  • Patient must give written informed consent before registration

Who cannot join

  • Prior radiotherapy to the brain
  • History of brain metastases
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Del Mar. Radiation Oncology Department

    Barcelona, 08009

Other trials in Spain

About this study

Official title: Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)

The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients.

In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.

Read the detailed description

Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy.

Because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss.

Previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives.

The main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus.

Being tested
Prophylactic cranial irradiation (PCI), Hippocampal avoidance 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.

  • Prophylactic cranial irradiation (PCI)Radiation

    Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week

  • Hippocampal avoidance PCIRadiation

    Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week

Study groups in NCT02397733
Study groupRoleWhat they receive
Prophylactic cranial irradiation (PCI)Active comparatorRadiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week
Receives: Radiation: Prophylactic cranial irradiation (PCI)
Hippocampal avoidance PCIExperimentalHippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week
Receives: Radiation: Hippocampal avoidance PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)

    Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation

    Measured: Change from baseline to 3 months

Secondary outcomes (6)

  1. Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)

    Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 6,12 and 24 months after radiation

    Measured: Change from baseline to 6,12 and 24 months

  2. Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)

    Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation

    Measured: Change from baseline to 3, 6,12 and 24 months

  3. Hippocampus volume (brain magnetic resonance imaging) (MRI)

    Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation

    Measured: Change from baseline to 3, 6,12 and 24 months

  4. Adverse effects (according to Common Toxicity Criteria for Adverse Effects)

    Evaluation of adverse effects according to Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 at 3, 6, 12 and 24 months after radiation

    Measured: Change from baseline to 3, 6,12 and 24 months

  5. Quality of life (measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)

    Evaluation of Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)

    Measured: Change from baseline to 3, 6,12 and 24 months

  6. Overall survival

    From the start date of PCI until the date of death from any cause, or the last follow-up date whichever came first, assessed up to 60months"

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2019
  4. Study completionDec 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02397733
Sponsor's protocol ID
PREMER-TRIAL
Status last verified
Jul 2021
First submitted
20 Mar 2015
Last updated
2 Aug 2021
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 39615412

  • Ishibashi 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

  • Rodriguez de Dios N, Counago F, Murcia-Mejia M, Rico-Oses M, Calvo-Crespo P, Samper P, Vallejo C, Luna J, Trueba I, Sotoca A, Cigarral C, Farre N, Manero RM, Duran X, Gispert JD, Sanchez-Benavides G, Rognoni T, Torrente M, Capellades J, Jimenez M, Cabada T, Blanco M, Alonso A, Martinez-San Millan J, Escribano J, Gonzalez B, Lopez-Guerra JL. Randomized Phase III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small-Cell Lung Cancer (PREMER): A GICOR-GOECP-SEOR Study. J Clin Oncol. 2021 Oct 1;39(28):3118-3127. doi: 10.1200/JCO.21.00639. Epub 2021 Aug 11.

    PubMed 34379442

  • Rodriguez de Dios N, Counago F, Lopez JL, Calvo P, Murcia M, Rico M, Vallejo C, Luna J, Trueba I, Cigarral C, Farre N, Manero RM, Duran X, Samper P. Treatment Design and Rationale for a Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for SCLC: PREMER Trial on Behalf of the Oncologic Group for the Study of Lung Cancer/Spanish Radiation Oncology Group-Radiation Oncology Clinical Research Group. Clin Lung Cancer. 2018 Sep;19(5):e693-e697. doi: 10.1016/j.cllc.2018.05.003. Epub 2018 May 10.

    PubMed 29891263

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic cranial irradiation (PCI) and Hippocampal avoidance PCI in people with Small Cell Lung Carcinoma, run by Grupo de Investigación Clínica en Oncología Radioterapia at 1 site in Spain.

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 4 inclusion and 3 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 2 Aug 2021. 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 Spain. 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?

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 functioning (NCF) (Free and Cued Selective Reminding Test) (time frame: Change from baseline to 3 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 NCT02397733, which also lists 4 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 2 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in