Table 4 Currently accruing or upcoming clinical trials in response-adaptive adaptive radiotherapy (R-ART)
Clinical Trial | Primary Investigator (Location) | Description | Eligible | Target 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 years | 50 | Not 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 CRT | 100 (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 RT | 100 (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 hypopharynx | 268 | Recruiting (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 | 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 RT | Stage 1: 15 Stage 2: 60 Total: 75 | Recruiting (as of July 26, 2019) |