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Spots Global Cancer Trial Database for FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

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Trial Identification

Brief Title: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

Official Title: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study

Study ID: NCT05348486

Interventions

Dose escalation

Study Description

Brief Summary: Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.

Detailed Description: The radiotherapy protocol will include two dose-escalation regimens. The dose in hypoxic tumor volume will be escalated either by conventional RT or stereotactic radiotherapy technique. Concurrent chemotherapy cisplatin will be administered weekly 35-40 mg/m2 or every three weeks 80-100 mg/m2. The parameter of cumulative cisplatin dose of 200 mg/m2 during the whole course of radiotherapy will be also taken into account. Patients will be examined and monitored at least every two weeks. Target volumes and dose and fractionation: Definition of gross tumor volumes (GTV), clinical target volumes (CTV) and planning target volumes (PTV) will follow recommendations of DAHANCA, EORTC and RTOG guidelines. The conventional radiotherapy protocol: Standard fractionation regimen: 70 Gy/54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy in 33 fractions GTV LN bulky (\> 3cm) - PTV (5mm): for dose 70 Gy in 33 fractions LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy in 33 fractions Dose escalated radiotherapy protocol: Dose escalated radiotherapy protocol: 75,9 - 79,2 Gy in 33 fractions GTV hypoxic or any hypoxic LN \> 2cm - PTV (0mm): dose 75,9 - 79,2 Gy in 33 fractions (Contours must be subtracted and reduce by 3mm in case of close relation to the skin, bones or large blood vessels) GTV primary - CTV - PTV (5+5mm): for dose 70 Gy in 33 fractions LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy in 33 fractions

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The Masaryk Memorial Cancer Institute, Brno, , Czechia

Radiation oncology department in Palacký University and University Hospital Olomouc, Olomouc, , Czechia

Faculty Hospital Ostrava, Ostrava, , Czechia

Contact Details

Name: Martin Dolezel, Prof.

Affiliation: Palacký University and University Hospital Olomouc

Role: PRINCIPAL_INVESTIGATOR

Name: Marek Slavik, Ph.D.

Affiliation: The Masaryk Memorial Cancer Institute (MMCI)

Role: STUDY_CHAIR

Name: Jakub Cvek, Prof.

Affiliation: Faculty Hospital Ostrava

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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