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Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

ConditionHead and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMaria Sklodowska-Curie National Research Institute of Oncology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Do not meet the inclusion criteria.

Decompensated diabetes mellitus.

Myocardial infarction occurred up to 6 months before.

Pregnancy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic radiotherapy boost

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Stereotactic radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response to treatment

Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC).

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

Secondary outcomes

1

Evaluation of efficacy

Evaluation of overall survival (OS) time

Time frame
5 years after the end of treatment
2

Evaluation of efficacy

Evaluation of progression-free survival time (PFS)

Time frame
5 years after the end of treatment
3

Evaluation of efficacy

Evaluation of disease-free survival time (DFS)

Time frame
5 years after the end of treatment
4

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.

Time frame
5 years after the end of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Sklodowska-Curie National Research Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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