Table 2. Current dose escalation trials using IMRT for NSCLC.
Purpose | Title | ClinicalTrials.gov identifier | Status | Sponsor | Primary outcome |
---|---|---|---|---|---|
Using functional imaging to assess early response and dose escalate | Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC) | NCT01507428 | Ongoing, not recruiting | NCI | LRPFS; relative change in SUV peak from baseline to during-treatment PET/CT to LRPFS |
Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT) | NCT02773238 | Recruiting | UW | OS, compared to 60 Gy cohort of RTOG 0617 | |
Phase III Study of Individualized Adaptive Radiotherapy Based on PET/CT and 3DCRT/IMRT in Combination with Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC) | NCT02790190 | Recruiting | Shandong Cancer Hospital and Institute | OS | |
Using pre-treatment functional imaging to guide dose escalation | Dose Escalation by Boosting Radiation Dose Within the Primary Tumor on the Basis of a Pre-treatment FDG-PET-CT Scan in Stage IB, II and III NSCLC: A Randomized Phase II Trial | NCT01024829 | Recruiting | NKI | 1-year local progression-free survival rate |
A Randomized Phase II Trial to Assess the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy | NCT02788461 | Recruiting | Lawson Health Research Institute | Reduction of locoregional failure rate | |
Personalized dose escalation based on doses to OARs | Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non-Small Cell Lung Cancer (NSCLC) - A Feasibility Study | NCT01836692 | Ongoing, not recruiting | Heather Driscoll | Number of participants treated with isotoxic RT using IMRT and hyperfractionated accelerated RT |
INTENSE: A Phase I/II Study of Inhomogeneous Targeted Dose Escalation in Non-Small Cell Lung Cancer | NCT02764086 | Ongoing, not recruiting | Cancer Trials Ireland | Proportion of grade ≥3 toxicities related to RT | |
Phase I Dose Escalation Study of Accelerated Fractionation with Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esophageal Injury | NCT00921739 | Ongoing, not recruiting | DU | Maximum tolerated dose of IMRT |
IMRT, intensity-modulated radiation therapy; NSCLC, non-small cell lung cancer; NCI, National Cancer Institute; LRPFS, locoregional progression-free survival; SUV, standardized uptake value; PET/CT, positron emission tomography/computed tomography; UW, University of Washington; OS, overall survival; RTOG, Radiation Therapy Oncology Group; NKI, Netherlands Cancer Institute; OARs, organs at risk; RT, radiation therapy; DU, Duke University.