ArticleCancer medicine2025
Contemporary Characteristics and Outcomes of Pediatric Oncology Patients Participating in Early Phase Clinical Trials.
Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Moving toward precision communication in pediatric oncology clinical trials: An outline of a conceptual framework to support caregiver decision-making.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Optimizing the Efficacy-Toxicity Paradigm in Pediatric Oncology: A Narrative Review of Immunotherapy and Survivorship Outcomes.Current oncology (Toronto, Ont.) · 2026Review
- Contemporary Characteristics and Outcomes of Pediatric Oncology Patients Participating in Early Phase Clinical Trials.Cancer medicine · 2025Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundPhase 1 or phase 1/2 trials are a first step in pediatric cancer drug development. Currently, there is a paucity of information regarding contemporary outcomes for pediatric patients enrolled in these trials. We describe characteristics and outcomes of patients enrolled in pediatric phase 1 clinical trials over a 9-year period at a single institution.
methodsWe queried our clinical trials management system to generate a list of patients enrolled and treated on pediatric phase 1 or phase 1/2 trials from 2011 to 2019. We collected baseline demographics, clinical data, efficacy, and safety endpoints post-enrollment including: time to death, objective response to therapy, duration on therapy, need for dose modification, and occurrence of dose-limiting toxicity. Overall survival was calculated using Kaplan-Meier methods.
resultsA total of 224 unique patients accounted for 259 enrollments and 242 treatment episodes. The median age at enrollment was 11 years (range 0-27 years) and 56.2% were male. The majority were White (85.7%) and Non-Hispanic (88.2%). English was the primary language for 86.3% of patients, and 54.9% had private insurance. Solid tumors were the most common malignancy (41.0%), followed by brain tumors (34.1%), and hematologic malignancies (24.9%). Among treatment episodes, 49.3% received targeted monotherapy. After first enrollment, 27.6% of patients had an objective response to therapy (52.9% for hematologic malignancies, 20.5% for brain tumors, and 15.8% for solid tumors). The median duration of therapy was 1.5 months. Median overall survival from first enrollment for 218 patients treated with available vital status was 13.1 months. Toxicity outcomes included 27 patients (11.2%) requiring dose modification and 22 patients (9.0%) having a DLT.
conclusionsOverall survival is poor for patients in pediatric oncology early phase trials, despite approximately a quarter having an initial response. These data are informative for discussions between providers and families regarding outcomes after phase 1 trial participation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.