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Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck
Closed for proposals
Project Type
Project Code
E33035CRP
1766Approved Date
Status
Start Date
Expected End Date
Completed Date
16 June 2023Participating Countries
Description
Worldwide, head and neck squamous cell carcinomas (HNSCC) (1) comprise approximately 7% of all incident cancers, and of these 64% are seen in low and middle income countries (13). Life-style factors, in particular tobacco and alcohol consumption, are major etiological factors, although an increasing number of HNSCC cases are associated with viral infections (Epstein Barr Virus and Human Papillomavirus) (1). Radiation therapy (RT) alone or combined with cytotoxic or molecular targeted agents is a mainstream definitive treatment for previously untreated locally advanced disease. This therapy offers organ and functional preservation in many cases with an approximate 30-50% of cases obtaining long-term loco-regional tumour control.
Accelerated RT, that is increasing the dose above the standard 10 Gy per week, has been shown in a large number of randomized controlled trials to be associated with an improved efficacy/toxicity ratio relative to standard fractionation, provided a careful balance between total dose, dose per fraction and overall treatment time is chosen. The attractive feature of this approach is that the total treatment time is shorter than the conventional treatment (4 vs. 7 weeks in this case), thus being convenient for the patient, and the department can increase 75% the number of treated patients with the same workload.
By optimizing fractionation of radiotherapy in a resource sparing combined modality approach, it is expected that Member States will benefit from the rational use of existing equipment and staff levels, decreasing costs, yet providing optimal treatment for patients. This CRP continues Agency’s research efforts which have improved the clinical practice in radiotherapy of locally advanced HNSCC cancer.
Objectives
To improve policies in MS concerning radiotherapy and cancer treatment for HNSCC, and ensuring effective and efficient utilization of current and future advanced cancer radiotherapy treatment technologies.
Specific objectives
To run a clinical trial to test a resource sparing fractionation regime to treat HNSCC (66 Gy given in 33 fractions (6 fractions per week) vs. 55 Gy given in 20 fractions (5 fractions per week).
To support at least two PhD students from developing countries, who will conduct radiobiological translational research studies
The protocol addresses an important topic in applied radiobiology: ie the optimal strategy to balance the potential gain in efficacy of treatment achievable by limiting tumour repopulation during radical head and neck radiotherapy with the decrease in overall dose required with hypofractionation to maintain equipoise in normal tissue toxicity. Data generated from this trial will provide information on the extent and timing of repopulation and the parameters for normal tissue repair processes. As such, the trial has potential for impact in radical radiotherapy beyond the field of head and neck oncology.
Impact
The clinical trial has had a very positive impact on the practice of radiotherapy in head-and-neck cancer patients in the participating centres. Centres acquired the skills of implementation of hypofractionated radiotherapy in head-and-neck cancer. While hypofractionation is a radiotherapy strategy that is becoming more mature and accepted in prostate and breast cancer, the concern about toxicity has made some radiation oncologists reluctant to apply it in head-and-neck cancer patients. In this regard, the HYPNO trial is ahead of its time, generating data on disease outcomes and toxicity in this particular population of patients.
In addition, the practice of hypofractionated regimes contributes to shorter overall treatment times thus sparing resources and reducing waiting times for radiotherapy.
Additional impact has been the doctoral work of Dr. Misleidy Napoles in the use of biomarkers to predict the response to hypo- vs standard fractionation in head-and-neck cancer.
Relevance
Highly relevant.
The implementation of an hypofractionated radiotherapy schedule in head-and-neck cancers is both a potential improved strategy but also a challenge. The potential benefit lies on reducing the overall treatment time of radiotherapy, thus making it convenient to patients and resource-sparing for RT centres as a strategy to cope with waiting lists. However, the use of larger-than-standard doses per fraction (more than 1.8-2.0 Gy) may be followed by an increase in the acute and late toxicities of radiotherapy on the head-and-neck mucosal surfaces and the salivary glands. By testing an hypofractionated regimen of 2.75 Gy/fraction, this trial attempts to show non-inferiority with the DAHANCA Danish schedule while simultaneously monitoring the acute and late side effects.
In this regard, the HYPNO trial is very relevant generating and eventually publishing new data on the implementation and benefits of an hypofractionated regimen in patients with cancer of the head-and-neck.