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Early Response Evaluation of Proton Therapy by PET-imaging in Squamous Cell Carcinoma Located in the Head and Neck

NCT03513042 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2022-12-06

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

RADIATION

Intensity Modulated Proton Therapy (IMPT) +/- Chemotherapy

Standard of care: * IMPT (conventional fractionation \[35x1,55/2Gy, 5 fractions/week\] or accelerated fractionation \[35x1,55/2Gy, 6 fractions/week\]) * with or without concurrent cisplatin (100 mg/m2 \[d1, d22 and d43\] or 40 mg/m2 weekly) or cetuximab (weekly 400 mg/m2 in 2h followed by 250 mg/m2 in 1h)

Sponsors & Collaborators

  • HollandPTC

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Dennis Vriens, MD, PhD · Leiden University Medical Center (LUMC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2022-11-23
Completion
2022-11-23

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03513042 on ClinicalTrials.gov