All patients were required to have a planning computed tomography scan for dose calculation and to verify coverage of gross disease. Either standard (parallel-opposed) or forward-planned conformal techniques were allowed (but not intensity-modulated radiation therapy ). Sites potentially harboring subclinical disease (including a minimum of two nodal echelons beyond gross disease) were treated to 50 Gy, and areas adjacent to gross disease to 60 Gy. A dose of 70 Gy in 35 fractions over 7 weeks was delivered to gross disease using a shrinking field technique. Radiation therapy was the same in both arms.
#QARC FUNDING RESTRICTION TRIAL#
In total, 861 eligible patients from 82 centers in 16 countries were entered onto the trial between September 2002 and April 2005. 2 In brief, this trial was undertaken to test the benefit of adding the hypoxic cell cytotoxin tirapazamine (TPZ) to cisplatin (CIS) -based chemoradiotherapy in patients with locoregionally advanced squamous cell carcinoma of the head and neck. This secondary analysis was undertaken to investigate both of these issues in the context of the international Trans-Tasman Radiation Oncology Group 02.02 (TROG 02.02) trial (HeadSTART).ĭetails of the trial design, treatment regimens, and patient characteristics are provided in the companion paper to this report. With this design, it is assumed that incorrect delivery of the platform treatment will wash out in the randomization process, such that, while the absolute results may be adversely affected, the comparative efficacy of the two regimens being tested can still be validly assessed. Randomized trials of combined modality treatment commonly involve comparison of different regimens of one modality added to a platform treatment common to both arms of the trial. However, the magnitude of the penalty associated with incorrect delivery of radiotherapy in the combined modality treatment of advanced head and neck cancer has not been previously reported. 1 It is implicit in this rationale that each modality is delivered correctly in order to achieve optimum results. The rationale for combined modality treatment is that each modality will augment or complement the other(s) by independent action, interaction at the molecular level, or spatial cooperation.