Diffusion-weighted MRI-guided dose painting in patients with locoregionally advanced nasopharyngeal carcinoma treated with induction chemotherapy plus concurrent chemoradiotherapy: a randomized, controlled clinical trial
Abstract
PURPOSES
We hypothesized that diffusion-weighted MRI (DWI)-guided dose-painting intensity modulated radiation therapy (DP-IMRT) is associated with improved local tumor control and survival in locoregionally advanced nasopharyngeal carcinoma (NPC). The purpose of this randomized study was to compare the efficacy and toxicity of DWI-guided DP-IMRT to conventional MRI-based IMRT in locoregional advanced NPC.
METHODS
A total of 260 NPC patients with stage III-IVa disease were randomly assigned in a 1:1 ratio to receive induction chemotherapy followed by chemoradiotherapy by DWI-guided DP-IMRT (group A, n = 130) or conventional MRI-based IMRT (group B, n = 130) in this prospective clinical trial. In group A, subvolume GTVnx-DWI (gross tumor volume of nasopharynx in DWI) was defined as the areas within the GTVnx (gross tumor volume of nasopharynx) with an apparent diffusion coefficient (ADC) below the mean ADC (ADC < mean) according to MRI before induction chemotherapy. The dose to GTVnx-DWI was escalated to 75.2 Gy/32 Fx in patients with T1-2 disease and to 77.55 Gy/33 Fx in those with T3-4 disease in 2.35 Gy per fraction. In group B, PGTVnx was irradiated at 70.4-72.6 Gy/32-33 Fx in 2.2 Gy per fraction. This trial is registered with chictr.org.cn (number).
RESULTS
A total of 260 patients were included in the trial (130 patients in group A and 130 in group B). Complete response rates after chemoradiotherapy were 99.2% (129/130) and 93.8% (122/130) in groups A and B, respectively…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 260 participants or records.
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