Head and Neck Cancer
Conditions
Keywords
stereotactic radiotherapy, radiosurgery boost, head and neck cancer
Brief summary
The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H&N tumours.
Detailed description
Aims of the study: 1. Evaluation of the efficacy of the stereotactic boost applied in patients with head and neck tumours. 2. Evaluation of the safety of the stereotactic boost applied in patients with head and neck tumours. 3. Evaluation of the influence of the stereotactic radiotherapy boost on blood parameters reflecting tumour response (interleukin 6 (Il-6), thymidine kinase (TK), Fms-related tyrosine kinase 1 (sFlt-1)), and normal tissue response (C-reactive protein (CRP)). In the case of beneficial findings, the stereotactic radiosurgery boost in the course of radio(chemo)therapy in patients with head and neck tumours will be able to replace traditional techniques of radiation, and radical schemes of treatment will be possible for future development.
Interventions
RADIATIONStereotactic radiotherapy boost
A stereotactic radiosurgery boost is given in two cases: * Upfront boost-on the first day of overall treatment time (OTT) (to 6 days before beginning conventional radiotherapy). * Direct boost-on Days 43-49 of OTT in relation to conventional radiotherapy to total dose (TD) 70 Gy, i.e., up to 6 days after a dose of 60 Gy. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin 100 mg/m2 or 40 mg/m2 in a 21-day or 7-day cycle, respectively Patients who start the treatment from induction chemotherapy may have a chance to qualify for an upfront or direct boost, depending the evaluation of the response to systemic treatment Prescribed doses of stereotactic boost are in the range of 10-18 Gy
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with squamous cell carcinoma (SCC) or adenoid cystic carcinoma (ACC) of the H&N region qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy. 2. Patients with other malignant tumours of the H&N region (sarcomas, neuroendocrine carcinomas, differentiated carcinomas, undifferentiated carcinomas, or basaloid carcinomas) qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy. 3. Patients with nonmalignant tumours of the H&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy. 4. Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12 5. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 6. Conscious agreement to participate in the clinical trial.
Exclusion criteria
1. Do not meet the inclusion criteria. 2. Decompensated diabetes mellitus. 3. Myocardial infarction occurred up to 6 months before. 4. Pregnancy. 5. Mental disorder preclusive of making a conscious agreement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to treatment | one month after the end of treatment, every 3 months in the first year, every 4 months in the second year, and every six months in the third-fifth years | Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of efficacy | 5 years after the end of treatment | Evaluation of overall survival (OS) time |
| Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0. | 5 years after the end of treatment | Acute and late side effects according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. |
| Treatment tolerance | an average of 3 months | Evaluation of quality of live anf reatment tolerance using QLQ-C30 (Quality of Life Questionnaire C30). |
Countries
Poland
Contacts
Primary ContactPaweł Polanowski, PhD
Backup ContactKrzysztof Skladowski
Outcome results
None listed