Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

NCT ID: NCT06472570

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-26
• Study Completion Date: 2030-12-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic radiotherapy

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

Group Type: EXPERIMENTAL

Stereotactic radiotherapy boost

Intervention Type: RADIATION

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

Interventions

Stereotactic 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

Intervention Type: RADIATION

Eligibility Criteria

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.

2. Decompensated diabetes mellitus.

3. Myocardial infarction occurred up to 6 months before.

4. Pregnancy.

5. Mental disorder preclusive of making a conscious agreement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paweł Polanowski

Role: PRINCIPAL_INVESTIGATOR

Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice

Locations

1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,

Gliwice, Gliwicw, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Paweł Polanowski, PhD

Role: CONTACT

pawel.polanowski@gliwice.nio.gov.pl

48322788313

Krzysztof Skladowski

Role: CONTACT

krzysztof.skladowski@gliwice.nio.gov.pl

48322788329

Facility Contacts

Pawel Polanowski

Role: primary

pawel.polanowski@gliwice.nio.gov.pl

48322788313

Other Identifiers

SterRad

Identifier Type: -

Identifier Source: org_study_id