1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,
Gliwice, Gliwicw, 44-102, Poland
Location status: Recruiting
Recruiting
NCT Number: NCT06472570
Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H&N tumours.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Aims of the study:
- Evaluation of the efficacy of the stereotactic boost applied in patients with head and neck tumours.
- Evaluation of the safety of the stereotactic boost applied in patients with head and neck tumours.
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
- 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.
- Patients with nonmalignant tumours of the H&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.
- Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Conscious agreement to participate in the clinical trial.
Exclusion criteria
- Do not meet the inclusion criteria.
- Decompensated diabetes mellitus.
- Myocardial infarction occurred up to 6 months before.
- Pregnancy.
- Mental disorder preclusive of making a conscious agreement
Treatment and study plan
Stereotactic radiotherapy boost
RadiationA 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
Primary outcomes
-
Response to treatment
Time frame: 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 outcomes
-
Evaluation of efficacy
Time frame: 5 years after the end of treatment
Evaluation of overall survival (OS) time
-
Evaluation of efficacy
Time frame: 5 years after the end of treatment
Evaluation of progression-free survival time (PFS)
-
Evaluation of efficacy
Time frame: 5 years after the end of treatment
Evaluation of disease-free survival time (DFS)
-
Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0.
Time frame: 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
Time frame: an average of 3 months
Evaluation of quality of live anf reatment tolerance using QLQ-C30 (Quality of Life Questionnaire C30).
Study contacts
Contact information is provided by the study sponsor or research team.
Krzysztof Skladowski
CONTACT
Paweł Polanowski, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Other
Registry information
Official study title
Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Important dates
- Study start
- 2019
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Jun 25, 2024
- Registry last updated
- Jun 25, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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