FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— FARHEAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348486
• Other study ID #: 22-03-00435
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: June 30, 2030

Study information

• Verified date: January 2024
• Source: University Hospital Olomouc
• Contact: Martin Dolezel, Prof
• Phone: +420588444295
• Email: dolezelm[@]email.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dose Escalation
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypoxia

Intervention

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

Locations

Country	Name	City	State
Czechia	The Masaryk Memorial Cancer Institute	Brno
Czechia	Radiation oncology department in Palacký University and University Hospital Olomouc	Olomouc
Czechia	Faculty Hospital Ostrava	Ostrava

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Olomouc	Masaryk Memorial Cancer Institute, University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	response rate	2-year
Primary	Locoregional progresion free survival	locoregional progresion free survival	2-year
Primary	Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0	acute radiation-induced events	3 months
Primary	Rate of late radiation-induced events according to CTCAE 5.0	late radiation-induced events	2-year
Secondary	Overall survival	overall survival	4 years
Secondary	Distant metastasis free survival	distant metastasis free survival	4 years
Secondary	Change in QoL according to the standardised EQ-5D questionnaire	QoL according to the standardised EQ-5D questionnaire	2 years
Secondary	Rate of new hypoxic areas after two weeks of radiotherapy	rate of new hypoxic areas after two weeks of radiotherapy	2 week after start of radiotherapy