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

Autor: Xavier Duran, Patricia Calvo, Núria Farré, Rosa Maria Manero, Carmen Vallejo, Felipe Couñago, Pilar Samper, Itziar Trueba, Javier Ras Luna, José Luis López, Mauricio Murcia, Mikel Rico, Nuria Rodríguez de Dios, Cristina Cigarral
Rok vydání: 2017
Předmět:
Pulmonary and Respiratory Medicine
Oncology
Adult
Male
Cancer Research
medicine.medical_specialty
Lung Neoplasms
Adolescent
Hippocampus
law.invention
03 medical and health sciences
Young Adult
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Internal medicine
medicine
Hippocampal sparing
Humans
Lung cancer
Aged
Aged
80 and over
medicine.diagnostic_test
business.industry
Memory function
Patient Selection
Radiotherapy Planning
Computer-Assisted
Magnetic resonance imaging
Middle Aged
medicine.disease
Prognosis
Primary tumor
Neurocognitive function
Small Cell Lung Carcinoma
Clinical research
Research Design
030220 oncology & carcinogenesis
Conventional PCI
Quality of Life
Female
Prophylactic cranial irradiation
Cranial Irradiation
business
Organ Sparing Treatments
030217 neurology & neurosurgery
Zdroj: Clinical Lung Cancer
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname
ISSN: 1938-0690
1525-7304
Popis: Background: Prophylactic cranial irradiation (PCI) is part of the usual treatment in most patients with small-cell lung cancer (SCLC) and response after treatment of the primary tumor. Clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy might play a role in radiation-induced neurocognitive decline. Patients and Methods: This study is a multicenter phase III trial (NCT02397733) randomizing SCLC patients after informed consent, to receive standard PCI treatment or PCI with hippocampus avoidance (PCI-HA) by using intensity modulated radiation therapy or volumetric modulated arc therapy. The primary objective is assessment of hippocampus-dependent memory functioning and safety after PCI with or without hippocampus sparing by the Free and Cued Selective Reminding Test. Secondary objectives are assessment of other neurotoxicity/quality of life, radiological brain abnormalities on magnetic resonance images, and evaluation of the incidence and location of brain metastases after PCI-HA compared with standard PCI. The originally planned sample size (n = 150) has been calculated to detect a 50% difference in the 3-month delayed recall score between the 2 treatment arms, with a statistical power of 80% (beta = 20%) and a significance level of 5% (alpha = 5%), with a maximum loss to follow-up of 10%. Conclusion: This study is an important step in introducing a new therapeutic approach to patients with SCLC candidates for PCI. (C) 2018 Elsevier Inc. All rights reserved.
Databáze: OpenAIRE
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