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Clinical Trials in Poland / NCT06472570
Recruiting Not applicable

Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

NCT06472570 · tracked via the Priya Life Science Poland tracker
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Phase
Not applicable
Started
2019-10-26
Last updated
2024-06-25

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

Stereotactic radiotherapy boost

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

Study summary

The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\&N tumours.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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. 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

Primary outcome measure(s)

  • 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).

Trial sites (1)

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

More Maria Sklodowska-Curie National Research Institute of Oncology trials in Poland

Stereotactic Radiosurgery in the Treatment of Essential Tremor Recruiting
Functional Abdominal Wall Reconstruction Active, not recruiting
Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma. Active, not recruiting
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial Active, not recruiting
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines Active, not recruiting

Other trials for the same condition

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE) Recruiting
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06472570 on ClinicalTrials.gov ↗ ← All trials in Poland