Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Maria Sklodowska-Curie National Research Institute of Oncology
80 participants
Oct 26, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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.
- Decompensated diabetes mellitus.
- Myocardial infarction occurred up to 6 months before.
- Pregnancy.
- Mental disorder preclusive of making a conscious agreement
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06472570