FARHEAD: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose escalation 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
Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN > 2cm
|
| No Intervention: Standard fractionation 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 |
Outcome Measures
Primary Outcome Measures
- Complete response rate [2-year]
response rate
- Locoregional progresion free survival [2-year]
locoregional progresion free survival
- Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0 [3 months]
acute radiation-induced events
- Rate of late radiation-induced events according to CTCAE 5.0 [2-year]
late radiation-induced events
Secondary Outcome Measures
- Overall survival [4 years]
overall survival
- Distant metastasis free survival [4 years]
distant metastasis free survival
- Change in QoL according to the standardised EQ-5D questionnaire [2 years]
QoL according to the standardised EQ-5D questionnaire
- Rate of new hypoxic areas after two weeks of radiotherapy [2 week after start of radiotherapy]
rate of new hypoxic areas after two weeks of radiotherapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1
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Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Adequate kidney and liver function
Exclusion Criteria:
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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)
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Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer
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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
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Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
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Known active Hepatitis B or C
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History of Human Immunodeficiency Virus (HIV)
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History of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
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Previous allogeneic tissue/solid organ transplant
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Active infection requiring systemic therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Masaryk Memorial Cancer Institute | Brno | Czechia | ||
| 2 | Radiation oncology department in Palacký University and University Hospital Olomouc | Olomouc | Czechia | ||
| 3 | Faculty Hospital Ostrava | Ostrava | Czechia |
Sponsors and Collaborators
- University Hospital Olomouc
- Masaryk Memorial Cancer Institute
- University Hospital Ostrava
Investigators
- Principal Investigator: Martin Dolezel, Prof., Palacký University and University Hospital Olomouc
- Study Chair: Marek Slavik, Ph.D., The Masaryk Memorial Cancer Institute (MMCI)
- Study Chair: Jakub Cvek, Prof., Faculty Hospital Ostrava
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-03-00435