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PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) | Clinical Trials | Clareo Health

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PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

NCT04790253•European Organisation for Research and Treatment of Cancer - EORTC

View on ClinicalTrials.gov

Summary

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

Detailed Description

The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: * To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. * To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. * To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. * To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. * To compare brain-metastasis-free survival (BMFS) between the arms. * To compare progression free survival (PFS) between the arms. * To compare time to brain-metastasis-attributed death (TBMAD) between the arms. * To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. * To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. * To collect blood for biobanking.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years
•Histologically/cytologically proven diagnosis of SCLC
•Limited and extensive stage
•LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan.
•ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan.
•Completed standard therapy prior to randomization:
•For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated.
•For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy
•o Immunotherapy concurrent with and/or adjuvant to standard therapy is allowed at the discretion of the treating physician.
•Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), 28 days before randomization.
+17 more criteria

Exclusion Criteria

•Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization.
•Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies.
•Other active hematologic or solid tumour malignancy requiring current active treatment.
•Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization.
•Patient with severe active comorbidities, defined as follows:
•Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
•Transmural myocardial infarction within 6 months prior to randomization
•Acute infection requiring treatment at the time of randomization
•Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
•Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
+4 more criteria

Locations (41)

Medical University of Graz - Radio-oncology

Graz, Austria

Institut Jules Bordet

Anderlecht, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

AZ Groeninge Kortrijk - Campus Kennedylaan

Kortrijk, Belgium

C.H.U. Sart-Tilman

Liège, Belgium

Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

Wilrijk, Belgium

Institut Sainte Catherine (UNICANCER)

Avignon, France

Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)

Bayonne, France

Institut Bergonie (UNICANCER)

Bordeaux, France

Centre Francois Baclesse (CLCC) (UNICANCER)

Caen, France

Key Dates

Start Date

October 27, 2022

Primary Completion Date

April 1, 2028

Completion Date

April 1, 2028

Last Updated

November 3, 2023

Enrollment

600

ESTIMATED participants

Conditions

Limited Stage Small Cell Lung CancerExtensive-stage Small-cell Lung Cancer

Interventions

Prophylactic cranial irradiation

RADIATION

Contacts

EORTC Reception

CONTACT

+3227741611 eortc@eortc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

Inclusion Criteria

Exclusion Criteria

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

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Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy