Head and Neck CancerFARHEADNCT05348486
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
A study testing Dose escalation in people with Head and Neck Cancer and Hypoxia, run by University Hospital Olomouc at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Hypoxia, FMISO
- What is being tested?
- Dose escalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesCzechia
- Study dates
- 20 Apr 2022to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area
- Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1
- Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate kidney and liver function
Who cannot join
- Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary)
- Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer
- Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
- Known active Hepatitis B or C
- History of Human Immunodeficiency Virus (HIV)
Show all 9Show fewer
- History of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
- Previous allogeneic tissue/solid organ transplant
- Active infection requiring systemic therapy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites, 3 recruiting
- Recruiting
The Masaryk Memorial Cancer Institute
Brno
Marek Slavik, Ph.d.
- Recruiting
Radiation oncology department in Palacký University and University Hospital Olomouc
Olomouc
Martin Dolezel, Prof, +420588444295, dolezelm@email.cz
- Recruiting
Faculty Hospital Ostrava
Ostrava
Jakub Cvek, Ass.Prof.
About this study
Official title: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
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.
Read the 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
- Conditions
- Head and Neck Cancer, Hypoxia, FMISO, Dose Escalation
- Being tested
- Dose escalation
- Keywords
- Head and Neck Cancer, Hypoxia, Radiotherapy, Dose escalation
- Medical subject headings
- Head and Neck Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalationRadiation
Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN > 2cm
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | 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/33 (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/33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy/33 Receives: Radiation: Dose escalation |
| Standard fractionation | No intervention | Standard fractionation regimen: 70 Gy/54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy/33 GTV LN bulky (> 3cm) - PTV (5mm): for dose 70 Gy/33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy/33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
response rate
Measured: 2-year
Locoregional progresion free survival
locoregional progresion free survival
Measured: 2-year
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
acute radiation-induced events
Measured: 3 months
Rate of late radiation-induced events according to CTCAE 5.0
late radiation-induced events
Measured: 2-year
Secondary outcomes (4)
Overall survival
overall survival
Measured: 4 years
Distant metastasis free survival
distant metastasis free survival
Measured: 4 years
Change in QoL according to the standardised EQ-5D questionnaire
QoL according to the standardised EQ-5D questionnaire
Measured: 2 years
Rate of new hypoxic areas after two weeks of radiotherapy
rate of new hypoxic areas after two weeks of radiotherapy
Measured: 2 week after start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Memorial Cancer Institute, University Hospital Ostrava
- Responsible party
- Principal investigator, Martin Dolezel, University Hospital Olomouc
- Investigators
- Martin Dolezel, Prof., Principal investigator, Palacký University and University Hospital OlomoucMarek Slavik, Ph.D., Study chair, The Masaryk Memorial Cancer Institute (MMCI)Jakub Cvek, Prof., Study chair, Faculty Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348486
- Sponsor's protocol ID
- 22-03-00435
- Acronym
- FARHEAD
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2022
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05348486
- Acronym / sponsor ID
- FARHEAD / 22-03-00435
- Conditions
- Head and Neck Cancer, Hypoxia, FMISO, Dose Escalation
- Keywords
- Head and Neck Cancer, Hypoxia, Radiotherapy, Dose escalation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Masaryk Memorial Cancer Institute, University Hospital Ostrava
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Radiation: Dose escalationDose 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/33 (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/33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy/33 |
| Standard fractionation | No intervention | –Standard fractionation regimen: 70 Gy/54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy/33 GTV LN bulky (> 3cm) - PTV (5mm): for dose 70 Gy/33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy/33 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area
- Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1
- Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate kidney and liver function
Key exclusion criteria (9 listed)
- Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary)
- Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer
- Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
- Known active Hepatitis B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose escalationDose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN > 2cm | Radiation | Dose escalation |
Primary outcome
Complete response rate
Time frame: 2-year
response rate
Locoregional progresion free survival
Time frame: 2-year
locoregional progresion free survival
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
Time frame: 3 months
acute radiation-induced events
Rate of late radiation-induced events according to CTCAE 5.0
Time frame: 2-year
late radiation-induced events
4 secondary outcomes
Overall survival
Time frame: 4 years
Distant metastasis free survival
Time frame: 4 years
Change in QoL according to the standardised EQ-5D questionnaire
Time frame: 2 years
Rate of new hypoxic areas after two weeks of radiotherapy
Time frame: 2 week after start of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Dolezel, Prof. principal investigator
Palacký University and University Hospital Olomouc
Marek Slavik, Ph.D. study chair
The Masaryk Memorial Cancer Institute (MMCI)
Jakub Cvek, Prof. study chair
Faculty Hospital Ostrava
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose escalation in people with Head and Neck Cancer and Hypoxia, run by University Hospital Olomouc at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Dolezel, Prof (+420588444295, dolezelm@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 2-year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.