Early Response Evaluation of Proton Therapy by PET-imaging in Squamous Cell Carcinoma Located in the Head and Neck (ERM-PT-HNSCC)
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|ClinicalTrials.gov Identifier: NCT03513042|
Recruitment Status : Not yet recruiting
First Posted : May 1, 2018
Last Update Posted : February 20, 2020
The goal of this project is to develop and characterise an imaging strategy for biology-guided individualisation of the proton therapy plan to improve patient outcome and quality-of-life.
Positron-emission tomography (PET) studies reflecting glucose metabolism, hypoxia and physical changes of proton-irradiated tumour tissues will be performed. Patients with head and neck cancer will be studied, as these individuals frequently experience recurrences within the radiation field, often with limited therapeutic options. Severe side-effects and functional impairment, deteriorating patients' quality-of-life, limited the use of dose-escalation in recent feasibility studies of photon therapy guided by individual PET-response. However, proton therapy, currently being introduced in the Netherlands, improves the precision of radiotherapy and thereby limits the side-effects caused by irradiation of neighbouring healthy tissues. Therefore, in proton therapy dose-escalation to improve patient outcome is less restricted by toxicity.
Using PET-studies of two hallmarks of radioresistance, glucose metabolism and hypoxia, side-by-side, before and early in-treatment, the predictive ability of both PET-techniques for local recurrence-free survival will be compared. A treatment plan adapted to the individual response measured by both procedures and compute tumour-dose and toxicity, will be simulated, thereby substantiating feasibility of image-guided adaptive replanning. Simultaneously to biological responses, proton therapy-induced physical changes will be studied. These atomic changes, dependent on tissue-composition and dose-deposition, are measurable by PET. It is expected that activation-PET to measure tissue-changes during therapy, a potential new biomarker of treatment efficacy, toxicity but also accuracy of treatment plan execution. Activation-PET will be related to earlier-mentioned PET-imaging of metabolism.
This clinical-technological project paves the way for an interventional trial of PET-guided treatment personalisation. Activation-PET will also serve as biomarker and quality control for proton therapy and support the current development of specialised in-beam PET-technology. These PET-techniques together will help us to individualise treatment, which is of great importance for the success and cost-effectiveness of proton therapy.
|Condition or disease||Intervention/treatment|
|Squamous Cell Carcinoma of the Head and Neck||Radiation: Intensity Modulated Proton Therapy (IMPT) +/- Chemotherapy|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Early Response Evaluation of Proton Therapy by PET-imaging in Squamous Cell Carcinoma Located in the Head and Neck|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||June 30, 2024|
- Standard of care Intensity Modulated Proton Therapy (IMPT) +/- Chemotherapy.
- All patients undergo baseline FDG PET-CT and FAZA PET-CT of the head-neck area.
Interim measurements conventional):
Radiation: Intensity Modulated Proton Therapy (IMPT) +/- Chemotherapy
Standard of care:
- 3-year local recurrence-free survival (LRFS) [ Time Frame: 3 years after start of IMPT ]This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HNSCC assessed by structured clinical and radiological (clinical) follow-up (paragraph 8.5). If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. Distant recurrence/progression and second cancers diagnosed before locoregional recurrence and death in absence of locoregional recurrence are not considered events of interest, but will be considered as competing risk events in the analysis of this endpoint. The 2-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated.
- 3-year overall survival [ Time Frame: 3 years after start of IMPT ]similar to LRFS but 'death from any cause' will be the event of interest
- 3-year disease-specific survival [ Time Frame: 3 years after start of IMPT ]similar to LRFS but 'death from HNSCC' will be the event of interest
- 3-year disease-free survival [ Time Frame: 3 years after start of IMPT ]similar to LRFS but 'any recurrence (including systemic)' will be the event of interest
- tumour response per RECIST [ Time Frame: 3 years after start of IMPT ]Response Evaluation Criteria In Solid Tumours (RECIST v1.1) tumour response during structured radiological follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513042
|Contact: Dennis Vriens, MD, PhD||+31715297709||D.Vriens@lumc.nl|
|Study Chair:||Dennis Vriens, MD, PhD||Leiden University Medical Center (LUMC)|