NCT02397733

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

5.1 years

First QC Date

March 20, 2015

Last Update Submit

July 27, 2021

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (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

    Change from baseline to 3 months

Secondary Outcomes (6)

  • Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)

    Change from baseline to 6,12 and 24 months

  • Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)

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

  • Hippocampus volume (brain magnetic resonance imaging) (MRI)

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

  • Adverse effects (according to Common Toxicity Criteria for Adverse Effects)

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

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

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

  • +1 more secondary outcomes

Study Arms (2)

Prophylactic cranial irradiation (PCI)

ACTIVE COMPARATOR

Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week

Radiation: Prophylactic cranial irradiation (PCI)

Hippocampal avoidance PCI

EXPERIMENTAL

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

Radiation: Hippocampal avoidance PCI

Interventions

Prophylactic cranial irradiation (PCI)RADIATION

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

Prophylactic cranial irradiation (PCI)
Hippocampal avoidance PCIRADIATION

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

Hippocampal avoidance PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Del Mar. Radiation Oncology Department

Barcelona, 08009, Spain

Location

Related Publications (4)

  • 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.

    PMID: 39615412DERIVED

  • 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.

    PMID: 34632876DERIVED

  • 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.

    PMID: 34379442DERIVED

  • 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.

    PMID: 29891263DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Núria Rodríguez de Dios, MD PhD

    +34683375231

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 25, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2019

Study Completion

December 1, 2020

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

ES(1)