Back to resultsFMISO-based Adaptive Radiotherapy for Head and Neck Cancer (FARHEAD)
Primary Purpose
Head and Neck Cancer, Hypoxia, FMISO
Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Dose escalation
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Hypoxia, Radiotherapy, Dose escalation
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
Sites / Locations
- The Masaryk Memorial Cancer Institute
- Radiation oncology department in Palacký University and University Hospital Olomouc
- Faculty Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dose escalation
Standard fractionation
Arm Description
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
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
Outcomes
Primary Outcome Measures
Complete response rate
response rate
Locoregional progresion free survival
locoregional progresion free survival
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
acute radiation-induced events
Rate of late radiation-induced events according to CTCAE 5.0
late radiation-induced events
Secondary Outcome Measures
Overall survival
overall survival
Distant metastasis free survival
distant metastasis free survival
Change in QoL according to the standardised EQ-5D questionnaire
QoL according to the standardised EQ-5D questionnaire
Rate of new hypoxic areas after two weeks of radiotherapy
rate of new hypoxic areas after two weeks of radiotherapy
Full Information
NCT ID
NCT05348486
First Posted
April 20, 2022
Last Updated
May 5, 2022
Sponsor
University Hospital Olomouc
Collaborators
Masaryk Memorial Cancer Institute, University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT05348486
Brief Title
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Acronym
FARHEAD
Official Title
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Olomouc
Collaborators
Masaryk Memorial Cancer Institute, University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Hypoxia, FMISO, Dose Escalation
Keywords
Head and Neck Cancer, Hypoxia, Radiotherapy, Dose escalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation
Arm Type
Experimental
Arm Description
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
Arm Title
Standard fractionation
Arm Type
No Intervention
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Dose escalation
Intervention Description
Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN > 2cm
Primary Outcome Measure Information:
Title
Complete response rate
Description
response rate
Time Frame
2-year
Title
Locoregional progresion free survival
Description
locoregional progresion free survival
Time Frame
2-year
Title
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
Description
acute radiation-induced events
Time Frame
3 months
Title
Rate of late radiation-induced events according to CTCAE 5.0
Description
late radiation-induced events
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
overall survival
Time Frame
4 years
Title
Distant metastasis free survival
Description
distant metastasis free survival
Time Frame
4 years
Title
Change in QoL according to the standardised EQ-5D questionnaire
Description
QoL according to the standardised EQ-5D questionnaire
Time Frame
2 years
Title
Rate of new hypoxic areas after two weeks of radiotherapy
Description
rate of new hypoxic areas after two weeks of radiotherapy
Time Frame
2 week after start of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dolezel, Prof.
Organizational Affiliation
Palacký University and University Hospital Olomouc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marek Slavik, Ph.D.
Organizational Affiliation
The Masaryk Memorial Cancer Institute (MMCI)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jakub Cvek, Prof.
Organizational Affiliation
Faculty Hospital Ostrava
Official's Role
Study Chair
Facility Information:
Facility Name
The Masaryk Memorial Cancer Institute
City
Brno
Country
Czechia
Facility Name
Radiation oncology department in Palacký University and University Hospital Olomouc
City
Olomouc
Country
Czechia
Facility Name
Faculty Hospital Ostrava
City
Ostrava
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
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