Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Stereotactic radiotherapy boost

• Registration Number: NCT06472570
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Timeline

• Study Start: 2019-10-26
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic radiotherapy	Stereotactic radiotherapy boost	Patients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
Evaluation of efficacy	5 years after the end of treatment	Evaluation of disease-free survival time (DFS)

Trial Locations

Locations (1)

1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,; 🇵🇱 Gliwice, Gliwicw, Poland