Trial reportJournal of neuro-oncology2011
Radiotherapy followed by adjuvant temozolomide with or without neoadjuvant ACNU-CDDP chemotherapy in newly diagnosed glioblastomas: a prospective randomized controlled multicenter phase III trial.
Trial report in Journal of neuro-oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Congress of neurological surgeons systematic review and evidence-based guidelines update on the role of chemotherapeutic management and antiangiogenic treatment of newly diagnosed glioblastoma in adults.Journal of neuro-oncology · 2020Pooled it
- Optimized Image-Based Surrogate Endpoints in Targeted Therapies for Glioblastoma: A Systematic Review and Meta-Analysis of Phase III Randomized Controlled Trials.Korean journal of radiology · 2020Pooled it
- Treatment of newly diagnosed glioblastoma in the elderly: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Temozolomide for high grade glioma.The Cochrane database of systematic reviews · 2013Pooled it
- Using a pre-radiation window to identify potentially active cytotoxic agents in adults with newly diagnosed glioblastoma.Neuro-oncology · 2025Review
- Glioblastoma and the search for non-hypothesis driven combination therapeutics in academia.Frontiers in oncology · 2022Review
- Temozolomide for immunomodulation in the treatment of glioblastoma.Neuro-oncology · 2018Review
- Convection enhanced delivery of cisplatin-loaded brain penetrating nanoparticles cures malignant glioma in rats.Journal of controlled release : official journal of the Controlled Release Society · 2017Article
- MR image-guided delivery of cisplatin-loaded brain-penetrating nanoparticles to invasive glioma with focused ultrasound.Journal of controlled release : official journal of the Controlled Release Society · 2017Article
- Curcumin potentiates the potent antitumor activity of ACNU against glioblastoma by suppressing the PI3K/AKT and NF-κB/COX-2 signaling pathways.OncoTargets and therapy · 2017Article
- Article
- Glioblastoma multiforme: emerging treatments and stratification markers beyond new drugs.The British journal of radiology · 2015Review
- The Role of End-of-Life Issues in the Design and Reporting of Cancer Clinical Trials: A Structured Literature Review.PloS one · 2015Review
- The value of temozolomide in combination with radiotherapy during standard treatment for newly diagnosed glioblastoma.Journal of neuro-oncology · 2013Article
- Intensity-modulated fractionated stereotactic radiotherapy with reduced margin for high grade gliomas: dosimetric analysis of sparing optic nerve & chiasm.Journal of radiosurgery and SBRT · 2013Article
- The role of chemotherapy in anaplastic astrocytoma patients.Journal of Korean Neurosurgical Society · 2012Article
- Inefficiencies in phase II to phase III transition impeding successful drug development in glioblastoma.Neuro-oncology advancesReview
- Characterizing benefit from temozolomide in MGMT promoter unmethylated and methylated glioblastoma: a systematic review and meta-analysis.Neuro-oncology advancesReview
- State of the neoadjuvant therapy for glioblastoma multiforme-Where do we stand?Neuro-oncology advancesReview
- Therapeutic approach beyond conventional temozolomide for newly diagnosed glioblastoma: Review of the present evidence and future direction.Indian journal of medical and paediatric oncology : official journal of Indian Society of Medical & Paediatric OncologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A prospective randomized controlled multicenter phase III trial was conducted to evaluate the effects of neoadjuvant chemotherapy with nimustine (ACNU)-cisplatin (CDDP) when used in conjunction with radiotherapy plus adjuvant temozolomide in patients with newly diagnosed glioblastoma. The study population was randomly assigned into one treatment and one control group. Both groups received radiotherapy followed by six cycles of adjuvant oral temozolomide (150-200 mg/m(2)) for 5 days every 28 days after surgery. Prior to radiotherapy, the treatment group also received two cycles, 6 weeks apart, of neoadjuvant chemotherapy with ACNU (40 mg/m(2)/day) and CDDP (40 mg/m(2)/day) infused continuously for 72 h. The primary end-point was median survival time. The study has closed after interim analysis with a total of 82 patients (48.8% of target number) due to unacceptable high frequency of toxicity profiles in spite of the promising actuarial survival outcome. Median survival time was 28.4 months [90% confidence interval (CI), 21.1 months to not available] in the treatment group and 18.9 months (90% CI, 17.1-27.4 months) in the control group (P = 0.2). The 2-year survival rate and progression-free survival time were 50.9% and 6.6 months (90% CI, 3.5-9.5 months) in the treatment group and 27.8% and 5.1 months (90% CI, 3.8-8.8 months) in the control group. Grade 3 or 4 toxicity was documented in 26 (68.4%) patients in the treatment group, including three neutropenic fever and one death from sepsis, while grade 3 or 4 toxicity occurred in 6 patients (15.8%) in the control group. The high frequency of serious hematological toxicity with ACNU-CDDP neoadjuvant chemotherapy followed by radiotherapy and adjuvant temozolomide limits its usage as primary treatment for glioblastoma. Future studies should aim to identify a subpopulation at reduced risk for ACNU-CDDP toxicity so that the potential of this protocol can be realized.
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Registered trials
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