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Spots Global Cancer Trial Database for SPOG 2015 FN Definition. A Multi-center Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia

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Trial Identification

Brief Title: SPOG 2015 FN Definition. A Multi-center Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia

Official Title: SPOG 2015 FN Definition. A Swiss Pediatric Oncology Group (SPOG) Initiated Multi-center Open-label Randomized Controlled Multiple Crossover Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia (FN)

Study ID: NCT02324231

Study Description

Brief Summary: In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during FN. Patients are repeatedly randomized (cluster: study site) to the high or the low TLDF every month, resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed Poisson regression.

Detailed Description:

Keywords

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Basel: Universitätskinderklinik beider Basel, Basel, , Switzerland

Bern: Universitätsklinik für Kinderheilkunde, Inselspital, Bern, , Switzerland

Geneva: Département de Pédiatrie, Hôpital Cantonal de Genève, Geneva, , Switzerland

Lausanne: Hémato-Oncologie Pédiatrique, CHUV, Lausanne, , Switzerland

Luzern: Pädiatrische Hämatologie/Onkologie, Kinderspital, Lucerne, , Switzerland

Zürich: Pädiatrische Onkologie Kinderspital, Zurich, , Switzerland

Contact Details

Name: Roland A Ammann, MD

Affiliation: Universitätsklinik für Kinderheilkunde, Inselspital, Bern

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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