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Compliance to the prescribed dose and overall treatment time in five randomized clinical trials of altered fractionation in radiotherapy for head-and-neck carcinomas

Khalil, AA; Bentzen, SM; Bernier, J; Saunders, MI; Horiot, JC; Van Den Bogaert, W; Cummings, BJ; (2003) Compliance to the prescribed dose and overall treatment time in five randomized clinical trials of altered fractionation in radiotherapy for head-and-neck carcinomas. International Journal of Radiation Oncology Biology Physics , 55 (3) pp. 568-575.

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Abstract

Purpose: To investigate compliance to the prescribed dose- fractionation schedule in five randomized controlled trials of altered fractionation in radiotherapy for head-and-neck carcinoma. Methods and Materials: Individual patient data from 2566 patients participating in the European Organization for Research and Treatment of Cancer (EORTC) 22791, EORTC 22811, EORTC 22851, Princess Margaret Hospital (PMH), and continuous hyperfractionated accelerated radiotherapy (CHART) head-and- neck trials were merged in the fractionation IMPACT (Intergroup Merger of Patient data from Altered or Conventional Treatment schedules) study database. The ideal treatment time was defined as the minimum time required to deliver a prescribed schedule. Compliance to the prescribed overall treatment time was quantified as the difference between the actual and the ideal overall time. An overall measure of compliance in an individual patient, the total dose lost (TDL), was calculated as the dose lost due to prolongation of therapy (assuming a D-prolif of 0.64 Gy/day) plus the difference between the prescribed and the actual dose given. Results: The time in excess of the ideal ranged up to 97 days (average 3.9 days), and 25% of the patients had delays of 6 days or more. World Health Organization (WHO) performance status and nodal stage had a significant effect on TDL. TDL was significantly higher in the conventional than in the altered arm of the EORTC 22851 and CHART trials. In the PMH trial, TDL was significantly higher in the hyperfractionation than in the conventional arm. Centers participating in the three EORTC trials varied significantly in their compliance. There was a significant improvement in compliance in patients treated more recently. Conclusions: Even in randomized controlled trials, compliance to the prescribed radiation therapy schedule may be relatively poor, especially after conventional fractionation. This affects the interpretation of the outcome of these trials. (C) 2003 Elsevier Science Inc

Type: Article
Title: Compliance to the prescribed dose and overall treatment time in five randomized clinical trials of altered fractionation in radiotherapy for head-and-neck carcinomas
Additional information: Journal English Article ELSEVIER SCIENCE INC 1 MAR 1 648UJ NEW YORK Bentzen SM Mt Vernon Hosp, Gray Canc Inst, Grp Human Canc Biol & Infor, Northwood HA6 2JR, Middx, England INT J RADIAT ONCOL BIOL PHYS 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
Keywords: 97, ACCELERATED FRACTIONATION, Affect, altered fractionation, ARM, As, cancer, Carcinoma, CELL-CARCINOMA, cervix, clinical, Clinical trial, Clinical Trials, CLINICAL-TRIAL, CLINICAL-TRIALS, Compliance, continuous, CONTROLLED TRIAL, CONTROLLED TRIALS, CONVENTIONAL FRACTIONATION, database, delay, difference, DURATION, English, european, Head and neck, health, HYPERFRACTIONATION, impact, IMPROVEMENT, INTERRUPTIONS, LOCAL-CONTROL, Materials, May, Methods, Neck, ORGANIZATION, outcome, overall treatment time, Patient, patients, performance, PHYS, poor, radiation, Radiation therapy, RADIATION-THERAPY, Radiotherapy, randomized, RANDOMIZED CONTROLLED TRIAL, Randomized Controlled Trials, Research, Result, SCHEDULE, Science, SOUTH, therapy, TIME, treatment, TREATMENT TIME, TRIAL, TRIALS, USA, WORLD, World Health, World Health Organization
UCL classification: UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
URI: http://discovery.ucl.ac.uk/id/eprint/30499
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