Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Prospective Phase II Open-Label Randomized Controlled Trial to Compare Mandibular Preservation in Upfront Surgery With Neoadjuvant Chemotherapy Followed by Surgery in Operable Oral Cavity Cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 6 of them syntheses that pooled it.
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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.
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Who cites it
39 citing papers in PubMed, 6 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Randomized Controlled Trials Comparing the Standard of Care to Alternative Treatments in Patients with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Systematic Literature Review.Advances in therapy · 2026Pooled it
- Two-year follow-up outcomes of neoadjuvant therapy in oral squamous cell carcinoma: an exploratory systematic review and meta-analysis.BMC oral health · 2026Pooled it
- Meta-analysis to Investigate the Correlation Between Event-Free Survival and Overall Survival in Patients with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma.Advances in therapy · 2025Pooled it
- Evaluating the efficacy and safety of different neoadjuvant immunotherapy combinations in locally advanced HNSCC: a systematic review and meta-analysis.Frontiers in immunology · 2024Pooled it
- Interventions for the treatment of oral cavity and oropharyngeal cancers: surgical treatment.The Cochrane database of systematic reviews · 2023Pooled it
- Interventions for the treatment of oral cavity and oropharyngeal cancer: chemotherapy.The Cochrane database of systematic reviews · 2021Pooled it
- Neoadjuvant triplet chemotherapy enables radiotherapy avoidance in human papillomavirus-associated oropharyngeal cancer: a multicentre Phase II trial.British journal of cancer · 2026Article
- Integrating Immunotherapy Into Head and Neck Surgery: Bridging Tumor Biology to Perioperative Decision-Making, a Review.Head & neck · 2026Review
- Article
- Long-term follow-up of neoadjuvant chemotherapy in resectable human papillomavirus-associated oropharyngeal cancer.International journal of clinical oncology · 2026Article
- The emerging role of neoadjuvant immunotherapy in locally advanced oral squamous cell carcinoma: progress and challenges.International journal of surgery (London, England) · 2026Article
- Evaluation of neoadjuvant immunotherapy regimens for head and neck squamous cell carcinoma: a systematic review and single-arm and network meta-analysis.International journal of surgery (London, England) · 2026Article
- Mandibular preservation vs. sacrifice following neoadjuvant immunotherapy in locally advanced oral cancer: a comparative study of surgical and quality-of-life outcomes.Frontiers in oncology · 2026Article
- From Radical Resection to Precision Surgery: Integrating Diagnostic Biomarkers, Radiomics-Based Predictive Models, and Perioperative Systemic Therapy in Head and Neck Oncology.Diagnostics (Basel, Switzerland) · 2025Review
- Treatment Strategies for Oral Cavity and Oropharyngeal Squamous Cell Carcinoma: A Systematic Review of Neoadjuvant Chemotherapy and Transoral Robotic Surgery.Journal of pharmacy & bioallied sciences · 2025Article
- Neoadjuvant immunotherapy in squamous cell carcinoma of the head and neck: current evidence and future perspectives.Molecular cancer · 2025Review
- Article
- Neoadjuvant Treatment Approaches to Oral Cancer.Journal of clinical medicine · 2025Review
- A 40-year bibliometric analysis of global research on neoadjuvant chemotherapy for oral cancer (1985-2024).Discover oncology · 2025Article
- Defining response-adapted surgery after neoadjuvant therapy in oral cavity cancer.Oral oncology · 2025Review
Corrections and comments
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Authors and funding
18 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe objective of this study was to explore the potential role and safety of neoadjuvant chemotherapy (NACT) in tumor shrinkage and resultant mandibular preservation in oral cancers compared with conventional surgical treatment.
methodsThis study was a single-center, randomized, phase II trial of treatment-naive histologically confirmed squamous cell carcinoma of the oral cavity with cT2-T4 and N0/N+, M0 (American Joint Committee on Cancer, seventh edition) stage, necessitating resection of the mandible for paramandibular disease in the absence of clinicoradiologic evidence of bone erosion. The patients were randomly assigned (1:1) to either upfront surgery (segmental resection) followed by adjuvant treatment (standard arm [SA]) or two cycles of NACT (docetaxel, cisplatin, and fluorouracil) at 3-week intervals (intervention arm [IA]), followed by surgery dictated by postchemotherapy disease extent. All patients in the IA received adjuvant chemoradiotherapy, and patients in the SA were treated as per final histopathology report. The primary end point was mandible preservation rate. The secondary end points were disease-free survival and treatment-related toxicity.
resultsSixty-eight patients were enrolled over 3 years and randomly assigned to either SA (34 patients) or IA (34 patients). The median follow-up was 3.6 years (interquartile range, 0.95-7.05 years). Mandibular preservation was achieved in 16 of 34 patients (47% [95% CI, 31.49 to 63.24]) in the IA. The disease-free survival (
conclusionNACT plays a potential role in mandibular preservation in oral cancers with acceptable toxicities and no compromise in survival. However, this needs to be validated in a larger phase III randomized trial.
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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.