Abstract | PURPOSE: PATIENTS AND METHODS: The protocol required interventional review of radiotherapy plans by the Quality Assurance Review Center (QARC). All plans and radiotherapy documentation underwent post-treatment review by the Trial Management Committee (TMC) for protocol compliance. Secondary review of noncompliant plans for predicted impact on tumor control was performed. Factors associated with poor protocol compliance were studied, and outcome data were analyzed in relation to protocol compliance and radiotherapy quality. RESULTS: At TMC review, 25.4% of the patients had noncompliant plans but none in which QARC-recommended changes had been made. At secondary review, 47% of noncompliant plans (12% overall) had deficiencies with a predicted major adverse impact on tumor control. Major deficiencies were unrelated to tumor subsite or to T or N stage (if N+), but were highly correlated with number of patients enrolled at the treatment center (< five patients, 29.8%; > or = 20 patients, 5.4%; P < .001). In patients who received at least 60 Gy, those with major deficiencies in their treatment plans (n = 87) had a markedly inferior outcome compared with those whose treatment was initially protocol compliant (n = 502): -2 years overall survival, 50% v 70%; hazard ratio (HR), 1.99; P < .001; and 2 years freedom from locoregional failure, 54% v 78%; HR, 2.37; P < .001, respectively. CONCLUSION:
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Authors | Lester J Peters, Brian O'Sullivan, Jordi Giralt, Thomas J Fitzgerald, Andy Trotti, Jacques Bernier, Jean Bourhis, Kally Yuen, Richard Fisher, Danny Rischin |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 28
Issue 18
Pg. 2996-3001
(Jun 20 2010)
ISSN: 1527-7755 [Electronic] United States |
PMID | 20479390
(Publication Type: Journal Article, Multicenter Study)
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Chemical References |
- Triazines
- Tirapazamine
- Cisplatin
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Topics |
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Squamous Cell
(drug therapy, pathology, radiotherapy)
- Cisplatin
(administration & dosage)
- Clinical Trials as Topic
- Combined Modality Therapy
- Follow-Up Studies
- Guideline Adherence
- Head and Neck Neoplasms
(drug therapy, pathology, radiotherapy)
- Humans
- International Agencies
- Neoplasm Recurrence, Local
(drug therapy, pathology, radiotherapy)
- Neoplasm Staging
- Quality Assurance, Health Care
- Radiotherapy Dosage
- Survival Rate
- Tirapazamine
- Treatment Outcome
- Triazines
(administration & dosage)
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