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Table 4 Currently accruing or upcoming clinical trials in response-adaptive adaptive radiotherapy (R-ART)

From: Adaptive radiotherapy for head and neck cancer

Clinical TrialPrimary Investigator
(Location)
DescriptionEligibleTarget Accrual
(Actual or Current Accrual)
Status
PEARL PET-based Adaptive Radiotherapy Clinical Trial
(PEARL) [78]
Mererid Evans
(Velindre Cancer Centre, Wales, United Kingdom)
Prospective phase II feasibility study of biological dose adaptation using PET/CT at baseline and at 2 weeks
Primary Outcome: PFS at 2 years
P16-positive oropharyngeal SCC T1–3 N0–1 M0 being treated with definitive CRT and non-smoker for > 2 years50Not yet recruiting (as of May 2, 2019)
Comparison of Adaptive Dose Painting by Numbers with Standard Radiotherapy for Head and Neck Cancer
(C-ART-2) [72]
Wilfried de Neve, MD PhD
(University Hospital, Ghent, Belgium)
Randomized phase II trial randomizing participants to adaptive dose-painting-by-numbers or to standard radiation
Primary Outcome: LC at 1 year
SCC of the oral cavity, oropharynx, hypopharynx, or larynx which is T1–4 (or T3–4N0 or T1–4N1–3 if glottic) with decision for definitive RT or CRT100 (95)Active, not recruiting (as of May 21, 2018)
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial [80]Wilfried de Neve, MD PhD
(University Hospital, Ghent, B3elgium)
Randomized phase II trials randomizing participants to standard IMRT or to adaptive radiotherapy (with 2 re-scans with either CT, PET/CT, or MRI during treatment) with the objective to reduce elective neck volumes based on tumor response
Primary Outcome: Reduction of acute and late dysphagia
T1–4 N0–3 HNSCC receiving definitive RT100 (100)Completed, not yet published (as of January 27, 2016)
Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcome (ARTFORCE) [73, 74]Olga Hamming-Vrieze, MD
(The Netherlands Cancer Institute)
Randomized phase II trial randomizing participants in a factorial 2 by 2 design to cisplatin or cetuximab and standard RT 70Gy/35Fx or adaptive radiotherapy 70-84Gy/35Fx boosting the 50% SUV max inside the GTV, with re-scans at week 2
Primary Outcomes: 2 year grade 3+ toxicity, 2 year LRFS
AJCC 7 Stage III/IV SCC of the oropharynx, oral cavity, or hypopharynx268Recruiting (as of September 28, 2017)
Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy
(MR-ADAPTOR) [37, 79]
Clifton Fuller, MD PhD
(MD Anderson Cancer Center)
Phase II trial using weekly MRI imaging to assess treatment response and guide dose de-intensification by reducing the 69.96 Gy PTV volume as the tumor shrinks. Note the elective volumes will not change during R-ART and will receive a minimum of 50.16 Gy. Stage 2 will randomize participants to standard IMRT or MRI-guided RT.
Primary Outcome: LRC at 6 months
P16-positive T1–2 N0-2B (AJCC 7), lymph node < 3 cm, pack years < 10, receiving definitive RTStage 1: 15
Stage 2: 60
Total: 75
Recruiting (as of July 26, 2019)