Trial reportBMC cancer2009
RNOP-09: pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma--a phase II study.
Trial report in BMC cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02758366 (An Open-label, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Doxorubicin in Combination With Radiotherapy, Temozolomide and Valproic Acid in Patients With Glioblastoma Multiforme), which is not on this map. Cited by 65 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
An Open-label, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Doxorubicin in Combination With Radiotherapy, Temozolomide and Valproic Acid in Patients With Glioblastoma Multiforme (GBM) and Diffuse Intrinsic Pontine Glioma (DIPG)
Who cites it
65 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Exploring the effects of doxorubicin on survival rates in glioma patients: a comprehensive systematic review.European journal of medical research · 2025Pooled it
- Congress of neurological surgeons systematic review and evidence-based guidelines update on the role of emerging developments in the management of newly diagnosed glioblastoma.Journal of neuro-oncology · 2020Pooled it
- Progression-free survival as a surrogate endpoint for overall survival in glioblastoma: a literature-based meta-analysis from 91 trials.Neuro-oncology · 2014Pooled it
- Advancements in Drug Delivery Systems in Glioblastoma Therapy.International journal of molecular sciences · 2026Review
- Biomimetic PD-1-MSCs membrane-engineered nanoparticles for enhanced blood-brain barrier penetration and anti- glioma therapy.Frontiers in immunology · 2026Article
- Advancing glioblastoma therapy with surface-modified nanoparticles.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Review
- Evolving therapeutic strategies in glioblastoma: traditional approaches and novel interventions.3 Biotech · 2025Review
- Nanostructured lipid carriers for enhanced batimastat delivery across the blood-brain barrier: an in vitro study for glioblastoma treatment.Drug delivery and translational research · 2025Article
- Targeting the glioblastoma resection margin with locoregional nanotechnologies.Nature reviews. Clinical oncology · 2025Review
- Nanotechnology Driven Lipid and Metalloid Based Formulations Targeting Blood-Brain Barrier (3B) for Brain Tumor.Indian journal of microbiology · 2025Article
- Brain-targeting drug delivery systems: The state of the art in treatment of glioblastoma.Materials today. Bio · 2025Review
- Emerging Approaches in Glioblastoma Treatment: Modulating the Extracellular Matrix Through Nanotechnology.Pharmaceutics · 2025Review
- Comprehensive insights into glioblastoma multiforme: drug delivery challenges and multimodal treatment strategies.Therapeutic delivery · 2025Review
- Chemotherapeutic nanoparticles for glioblastoma.Frontiers in oncology · 2025Review
- Receptor-Assisted Nanotherapeutics for Overcoming the Blood-Brain Barrier.Molecular neurobiology · 2024Review
- Targeting the undruggable in glioblastoma using nano-based intracellular drug delivery.Medical oncology (Northwood, London, England) · 2024Review
- Blood-Brain Barrier Conquest in Glioblastoma Nanomedicine: Strategies, Clinical Advances, and Emerging Challenges.Cancers · 2024Review
- Current Non-Metal Nanoparticle-Based Therapeutic Approaches for Glioblastoma Treatment.Biomedicines · 2024Review
- An Overview on the Physiopathology of the Blood-Brain Barrier and the Lipid-Based Nanocarriers for Central Nervous System Delivery.Pharmaceutics · 2024Review
- Review
5 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough Temozolomide is effective against glioblastoma, the prognosis remains dismal and new regimens with synergistic activity are sought for.
methodsIn this phase-I/II trial, pegylated liposomal doxorubicin (Caelyx, PEG-Dox) and prolonged administration of Temozolomide in addition to radiotherapy was investigated in 63 patients with newly diagnosed glioblastoma. In phase-I, PEG-Dox was administered in a 3-by-3 dose-escalation regimen. In phase-II, 20 mg/m2 PEG-Dox was given once prior to radiotherapy and on days 1 and 15 of each 28-day cycle starting 4 weeks after radiotherapy. Temozolomide was given in a dose of 75 mg/m2 daily during radiotherapy (60 Gy) and 150-200 mg/m2 on days 1-5 of each 28-day cycle for 12 cycles or until disease progression.
resultsThe toxicity of the combination of PEG-Dox, prolonged administration of Temozolomide, and radiotherapy was tolerable. The progression free survival after 12 months (PFS-12) was 30.2%, the median overall survival was 17.6 months in all patients including the ones from Phase-I. None of the endpoints differed significantly from the EORTC26981/NCIC-CE.3 data in a post-hoc statistical comparison.
conclusionTogether, the investigated combination is tolerable and feasible. Neither the addition of PEG-Dox nor the prolonged administration of Temozolomide resulted in a meaningful improvement of the patient's outcome as compared to the EORTC26981/NCIC-CE.3 data.
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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.