{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T09:16:39Z","timestamp":1791278199797,"version":"4.1.0"},"reference-count":29,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"18","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2010,6,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Promising results in a randomized phase II trial with the hypoxic cytotoxin tirapazamine (TPZ) combined with cisplatin (CIS) and radiation led to this phase III trial. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients with previously untreated stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to receive definitive radiotherapy (70 Gy in 7 weeks) concurrently with either CIS (100 mg\/m<jats:sup>2<\/jats:sup>) on day 1 of weeks 1, 4, and 7 or CIS (75 mg\/m<jats:sup>2<\/jats:sup>) plus TPZ (290 mg\/m<jats:sup>2<\/jats:sup>\/d) on day 1 of weeks 1, 4, and 7 and TPZ alone (160 mg\/m<jats:sup>2<\/jats:sup>\/d) on days 1, 3, and 5 of weeks 2 and 3 (TPZ\/CIS). The primary end point was overall survival (OS). The planned sample size was 850, estimated to result in 334 deaths, which would provide 90% power to detect a difference in 2-year survival rates of 60% v 70% for CIS versus TPZ\/CIS, respectively (hazard ratio = 0.69). <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Eight hundred sixty-one patients were accrued from 89 sites in 16 countries. In an intent-to-treat analysis, the 2-year OS rates were 65.7% for CIS and 66.2% for TPZ\/CIS (TPZ\/CIS \u2013 CIS: 95% CI, \u22125.9% to 6.9%). There were no significant differences in failure-free survival, time to locoregional failure, or quality of life as measured by Functional Assessment of Cancer Therapy\u2013Head and Neck. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p> We found no evidence that the addition of TPZ to chemoradiotherapy, in patients with advanced head and neck cancer not selected for the presence of hypoxia, improves OS. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2009.27.4449","type":"journal-article","created":{"date-parts":[[2010,5,18]],"date-time":"2010-05-18T03:49:43Z","timestamp":1274154583000},"page":"2989-2995","source":"Crossref","is-referenced-by-count":334,"title":["Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group"],"prefix":"10.1200","volume":"28","author":[{"given":"Danny","family":"Rischin","sequence":"first","affiliation":[{"name":"From the Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria; Department of Radiation Oncology, QRI-Royal Brisbane Hospital, Brisbane, Queensland, Australia; Department of Radiation Oncology, Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Department of Radiation Oncology, Vall d'Hebron University Hospital, Barcelona, Spain;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lester J.","family":"Peters","sequence":"additional","affiliation":[{"name":"From the Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria; Department of Radiation Oncology, QRI-Royal Brisbane Hospital, Brisbane, Queensland, Australia; Department of Radiation Oncology, Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Department of Radiation Oncology, Vall d'Hebron University Hospital, Barcelona, Spain;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"O'Sullivan","sequence":"additional","affiliation":[{"name":"From the Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria; Department of Radiation Oncology, QRI-Royal Brisbane Hospital, Brisbane, Queensland, Australia; Department of Radiation Oncology, Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Department of Radiation Oncology, Vall d'Hebron University Hospital, Barcelona, Spain;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordi","family":"Giralt","sequence":"additional","affiliation":[{"name":"From the Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria; Department of Radiation Oncology, QRI-Royal Brisbane Hospital, Brisbane, Queensland, Australia; Department of Radiation Oncology, Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Department of Radiation Oncology, Vall d'Hebron University Hospital, Barcelona, Spain;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Fisher","sequence":"additional","affiliation":[{"name":"From the Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; 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