Dataset Information

Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial.

ABSTRACT:

Background

Current standard radiotherapy for oropharynx cancer (OPC) is associated with high rates of severe toxicities, shown to adversely impact patients' quality of life. Given excellent outcomes of human papilloma virus (HPV)-associated OPC and long-term survival of these typically young patients, treatment de-intensification aimed at improving survivorship while maintaining excellent disease control is now a central concern. The recent implementation of magnetic resonance image - guided radiotherapy (MRgRT) systems allows for individual tumor response assessment during treatment and offers possibility of personalized dose-reduction. In this 2-stage Bayesian phase II study, we propose to examine weekly radiotherapy dose-adaptation based on magnetic resonance imaging (MRI) evaluated tumor response. Individual patient's plan will be designed to optimize dose reduction to organs at risk and minimize locoregional failure probability based on serial MRI during RT. Our primary aim is to assess the non-inferiority of MRgRT dose adaptation for patients with low risk HPV-associated OPC compared to historical control, as measured by Bayesian posterior probability of locoregional control (LRC).

Methods

Patients with T1-2?N0-2b (as per AJCC 7th Edition) HPV-positive OPC, with lymph node <3?cm and <10 pack-year smoking history planned for curative radiotherapy alone to a dose of 70?Gy in 33 fractions will be eligible. All patients will undergo pre-treatment MRI and at least weekly intra-treatment MRI. Patients undergoing MRgRT will have weekly adaptation of high dose planning target volume based on gross tumor volume response. The stage 1 of this study will enroll 15 patients to MRgRT dose adaptation. If LRC at 6?months with MRgRT dose adaptation is found sufficiently safe as per the Bayesian model, stage 2 of the protocol will expand enrollment to an additional 60 patients, randomized to either MRgRT or standard IMRT.

Discussion

Multiple methods for safe treatment de-escalation in patients with HPV-positive OPC are currently being studied. By leveraging the ability of advanced MRI techniques to visualize tumor and soft tissues through the course of treatment, this protocol proposes a workflow for safe personalized radiation dose-reduction in good responders with radiosensitive tumors, while ensuring tumoricidal dose to more radioresistant tumors. MRgRT dose adaptation could translate in reduced long term radiation toxicities and improved survivorship while maintaining excellent LRC outcomes in favorable OPC.

Trial registration

ClinicalTrials.gov ID: NCT03224000; Registration date: 07/21/2017.

SUBMITTER: Bahig H

PROVIDER: S-EPMC6204434 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial.

Bahig Houda H Yuan Ying Y Mohamed Abdallah S R ASR Brock Kristy K KK Ng Sweet Ping SP Wang Jihong J Ding Yao Y Hutcheson Kate K McCulloch Molly M Balter Peter A PA Lai Stephen Y SY Al-Mamgani Abrahim A Sonke Jan-Jakob JJ van der Heide Uulke A UA Nutting Christopher C Li X Allen XA Robbins Jared J Awan Mussadiq M Karam Irene I Newbold Katherine K Harrington Kevin K Oelfke Uwe U Bhide Shreerang S Philippens Marielle E P MEP Terhaard Chris H J CHJ McPartlin Andrew J AJ Blanchard Pierre P Garden Adam S AS Rosenthal David I DI Gunn Gary B GB Phan Jack J Cazoulat Guillaume G Aristophanous Michalis M McSpadden Kelli K KK Garcia John A JA van den Berg Cornelis A T CAT Raaijmakers Cornelis P J CPJ Kerkmeijer Linda L Doornaert Patricia P Blinde Sanne S Frank Steven J SJ Fuller Clifton D CD

Clinical and translational radiation oncology 20180824

<h4>Background</h4>Current standard radiotherapy for oropharynx cancer (OPC) is associated with high rates of severe toxicities, shown to adversely impact patients' quality of life. Given excellent outcomes of human papilloma virus (HPV)-associated OPC and long-term survival of these typically young patients, treatment de-intensification aimed at improving survivorship while maintaining excellent disease control is now a central concern. The recent implementation of magnetic resonance image - gu ...[more]

PMID: 30386824

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Dataset Information

Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial.

Background

Methods

Discussion

Trial registration

Publications

Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial.

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