FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dose escalation.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Hypoxia, FMISO, Dose Escalation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
Overview
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
Interventions
- Radiation Dose escalation
Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN \> 2cm
Primary outcome measures
- Complete response rate [Time frame: 2-year]
- Locoregional progresion free survival [Time frame: 2-year]
- Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0 [Time frame: 3 months]
- Rate of late radiation-induced events according to CTCAE 5.0 [Time frame: 2-year]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 3 centers
- The Masaryk Memorial Cancer Institute — Brno
- Radiation oncology department in Palacký University and University Hospital Olomouc — Olomouc
- Faculty Hospital Ostrava — Ostrava
Identifiers
NCT: NCT05348486 · 22-03-00435