Trial reportJournal of cancer research and clinical oncology2023
In search of effective therapies: the current landscape of phase II trials in patients with advanced soft tissue sarcoma.
Trial report in Journal of cancer research and clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed.
- Pharmacologic Resistance in Soft Tissue Sarcomas: Mechanisms, Biomarkers, and Translational Therapeutic Strategies.Cancers · 2026Review
- KNTC1 and PRC1 define an immunosuppressive microenvironment and poor prognosis in liposarcoma.European journal of medical research · 2026Article
- Blood-based biomarkers in soft tissue sarcoma: Implications for immune checkpoint inhibitor therapy.International journal of cancer · 2025Review
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Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSoft tissue sarcomas (STS) are diagnosed in 4-6 cases per 100 000 people a year and are associated with an unfavorable prognosis. Around one-third of patients will develop metastatic disease that requires palliative systemic therapy. Current therapeutic options have limited activity, and new treatments are tested, mainly in phase II trials. There is high variability and no standardization of phase II designs. We aimed to analyze the current landscape of phase II studies in STS and evaluate how its statistical design can affect the results.
methodsFull-text phase II studies published in STS patients between 2005 and 2020 were identified and analyzed.
resultsWe have identified 102 trials, of which 77.4% were single-arm trials, 16.7% were randomized comparative trials (RCT), and 5.9% were randomized noncomparative trials. Including multiple cohorts, 22 randomized and 128 single-arm cohorts were analyzed. Nearly 80% of trials reported full statistical bases of the design. Over 20 different primary endpoints were used, with PFS as the most common in RCT trials (81.8%) and ORR (36.7%) and 3-months progression-free survival (PFS) rate (21.9%) in single-arm trials. Overall, 27.3% of RCT and 37.5% of single-arm trials were positive. Among single-arm trials, studies using 3- or 6-month rates were more often positive than those based on ORR.
conclusionsThere is high heterogeneity in sarcoma trial designs, mainly in primary-endpoint and hypotheses used for size calculation. There is an unmet need for standardization that will incorporate factors associated with the rarity of the disease, outcomes detected in previous trials and real-life studies, and specific characteristics of new therapeutic agents.
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