Head and Neck CancerNCT06472570
Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
A study testing Stereotactic radiotherapy boost in people with Head and Neck Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\&N tumours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Stereotactic radiotherapy boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 26 Oct 2019to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,
Gliwice, Gliwicw, 44-102
Pawel Polanowski, 48322788313, pawel.polanowski@gliwice.nio.gov.pl
Pawel Polanowski, PhD
About this study
Official title: Escalating a Biological Dose of Radiation in the Target Volume Applying 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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Stereotactic radiotherapy boost
- Keywords
- stereotactic radiotherapy, radiosurgery boost, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapy boostRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiotherapy | Experimental | Patients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin Receives: Radiation: Stereotactic radiotherapy boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC).
Measured: 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
Secondary outcomes (5)
Evaluation of efficacy
Evaluation of overall survival (OS) time
Measured: 5 years after the end of treatment
Evaluation of efficacy
Evaluation of progression-free survival time (PFS)
Measured: 5 years after the end of treatment
Evaluation of efficacy
Evaluation of disease-free survival time (DFS)
Measured: 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.
Measured: 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).
Measured: an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start26 Oct 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paweł Polanowski, Principal investigator, Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472570
- Sponsor's protocol ID
- SterRad
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42216211
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
- ClinicalTrials.gov ID
- NCT06472570
- Acronym / sponsor ID
- SterRad
- Conditions
- Head and Neck Cancer
- Keywords
- stereotactic radiotherapy, radiosurgery boost, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- 26 Oct 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiotherapy | Experimental | Radiation: Stereotactic radiotherapy boostPatients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiotherapy boostA 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 | Radiation | Stereotactic radiotherapy |
Primary outcome
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).
5 secondary outcomes
Evaluation of efficacy
Time frame: 5 years after the end of treatment
Evaluation of efficacy
Time frame: 5 years after the end of treatment
Evaluation of efficacy
Time frame: 5 years after the end of treatment
Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0.
Time frame: 5 years after the end of treatment
Treatment tolerance
Time frame: an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 42216211Polanowski 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paweł Polanowski principal investigator
Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiotherapy boost in people with Head and Neck Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paweł Polanowski, PhD (48322788313, pawel.polanowski@gliwice.nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06472570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.