FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

NCT05348486 | Recruiting DMC

• 1 other identifier: 22-03-00435
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Head and Neck Cancer; Hypoxia; FMISO; Dose Escalation

Keywords

Head and Neck Cancer; Hypoxia; Radiotherapy; Dose escalation

Outcome Measures

Primary Outcomes (4)

• Complete response rate

  response rate

  2-year

• Locoregional progresion free survival

  locoregional progresion free survival

  2-year

• Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0

  acute radiation-induced events

  3 months

• Rate of late radiation-induced events according to CTCAE 5.0

  late radiation-induced events

  2-year

Secondary Outcomes (4)

• Overall survival

  4 years

• Distant metastasis free survival

  4 years

• Change in QoL according to the standardised EQ-5D questionnaire

  2 years

• Rate of new hypoxic areas after two weeks of radiotherapy

  2 week after start of radiotherapy

Study Arms (2)

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

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

Interventions

Dose escalation RADIATION

Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN \> 2cm

Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Masaryk Memorial Cancer Institute: collaborator
• University Hospital Ostrava: collaborator

Study Sites (3)

The Masaryk Memorial Cancer Institute

Brno, Czechia

RECRUITING

Radiation oncology department in Palacký University and University Hospital Olomouc

Olomouc, Czechia

RECRUITING

Faculty Hospital Ostrava

Ostrava, Czechia

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Dolezel, Prof.

  Palacký University and University Hospital Olomouc

  PRINCIPAL INVESTIGATOR

• Marek Slavik, Ph.D.

  The Masaryk Memorial Cancer Institute (MMCI)

  STUDY CHAIR

• Jakub Cvek, Prof.

  Faculty Hospital Ostrava

  STUDY CHAIR

Central Study Contacts

Martin Dolezel, Prof

CONTACT

+420588444295; dolezelm@email.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Martin Dolezel, M.D., Ph.D.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 27, 2022
• Study Start: April 20, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

CZ (3)