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The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H&N tumours.
Aims of the study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic radiotherapy | Experimental | Patients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiotherapy boost | Radiation | A stereotactic radiosurgery boost is given in two cases:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment | Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of efficacy | Evaluation of overall survival (OS) time | 5 years after the end of treatment |
| Evaluation of efficacy | Evaluation of progression-free survival time (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Polanowski, PhD | Contact | 48322788313 | pawel.polanowski@gliwice.nio.gov.pl | |
| Krzysztof Skladowski | Contact | 48322788329 | krzysztof.skladowski@gliwice.nio.gov.pl |
| Name | Affiliation | Role |
|---|---|---|
| Paweł Polanowski | Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, | Recruiting | Gliwice | Gliwicw | 44-102 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42216211 | Derived | Polanowski P, Tukiendorf A, Nasiek A, Grzadziel A, Pietruszka A, Polanowska K, Rutkowski T, Skladowski K. High-dose stereotactic radiotherapy boost in the radical treatment of head and neck tumors. Radiat Oncol. 2026 May 29. doi: 10.1186/s13014-026-02857-2. Online ahead of print. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 5 years after the end of treatment |
| Evaluation of efficacy | Evaluation of disease-free survival time (DFS) | 5 years after the end of treatment |
| Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0. | Acute and late side effects according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. | 5 years after the end of treatment |
| Treatment tolerance | Evaluation of quality of live anf reatment tolerance using QLQ-C30 (Quality of Life Questionnaire C30). | an average of 3 months |
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