Work Package 5 (WP5): clinical implementation of the personalised radiotherapy + hyperthermia treatment planning platform

Research question: to implement personalised HT treatment planning in a clinical study accompanied by dose monitoring during treatment and tumor response monitoring, using imaging and tumor markers. The significant and clinically relevant benefit of adding HT to RT has been demonstrated in

Randomised clinical trials have demonstrated a major clinical benefit when adding hyperthermia to radiotherapy or chemoradiation for a variety of tumors including cervical cancer, recurrent breast cancer, head and neck cancer. Though successful, opinions differ regarding the optimal frequency, temperature level, sequence and time interval between hyperthermia and radiotherapy. For instance, some clinicians prefer long time intervals to obtain maximum tumor selectiveness , others opt for short intervals to maximise likelihood of tumor control.

Aim of WP5 is to provide the framework for clinical implementation of personalised radiotherapy + hyperthermia planning. This involves all relevant aspects of the clinical application, including standardized protocols with tight quality assurance as well as implementing standardised dose and tumor response monitoring procedures. Six ESRs will work in WP5.

ESR9 will work on meticulous Quality Assurance protocols for the clinical implementation of radiotherapy and hyperthermia treatments to ensure that actual hyperthermia system settings accurately match the system setting prescription by the planning platform.

ESR10 will prepare and implement similar protocols to ensure that sufficient technical and clinical data are reported to allow meaningful clinical analysis of treatment outcome.

ESR11 and ESR 12 will develop, implement and evaluate novel tumor marker and imaging techniques, respectively. These techniques will permit tumor and immune response monitoring during the 4-5 week course of radiotherapy and hyperthermia treatments. This feedback will permit individualised re-planning during the treatment course and show the effective and dynamic contribution of each hyperthermia mechanism for individual patients.

ESR13 will setup prospective clinical registration studies to evaluate the clinical benefit of personalised radiotherapy + hyperthermia treatment planning. These studies should start at the end of the programme, and pave the way for randomised clinical trials starting after Hyperboost.

ESR14 will derive clinical correlations between treatment response and radiotherapy + hyperthermia dose, sequence, time intervals from existing patients cohorts. These data are useful for the radiotherapy + hyperthermia planning platform of WP4, and complement the pre-clinical data of WP3.