Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06307015
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-01
Brief Title:
De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET DE-RADIATE
Sponsor:
Royal North Shore Hospital
Organization:
Royal North Shore Hospital
Study Overview
Official Title:
De-escalation of Radiation Dose in HPV-associated Oropharyngeal Squamous Cell Carcinoma Utilising FMISO PET and Magnetic Resonance Imaging as Non-Invasive Biomarkers of Hypoxia DE-RADIATE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DE-RADIATE
Brief Summary:
The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy
The main questions it aims to answer are
1 What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection
2 What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT
3 What are the acute and late toxicities in patients selected for radiation dose de-escalation
4 What are the quality of life scores in patients selected for radiation dose de-escalation
5 What are the local regional and distant failure rates of patients selected for radiation dose de-escalation
Patients with cT1-2N1-2b AJCC 7th edition oropharyngeal tumours will undergo surgical resection of the primary tumour Following this they will be allocated to standard radiation therapy 70Gy with concurrent cisplatin chemotherapy or de-escalation radiation therapy 30Gy with concurrent cisplatin chemotherapy based on the results of FMISO PET Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group 3-4 months after completion of radiation therapy all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response
Researchers will assess the pathologic response rate after surgery in the de-escalation group They will also compare the outcomes oncological outcomes and quality of life between the group receiving the standard treatment 70Gy and the group receiving de-escalated radiation therapy 30Gy
The main questions it aims to answer are
1 What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection
2 What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT
3 What are the acute and late toxicities in patients selected for radiation dose de-escalation
4 What are the quality of life scores in patients selected for radiation dose de-escalation
5 What are the local regional and distant failure rates of patients selected for radiation dose de-escalation
Patients with cT1-2N1-2b AJCC 7th edition oropharyngeal tumours will undergo surgical resection of the primary tumour Following this they will be allocated to standard radiation therapy 70Gy with concurrent cisplatin chemotherapy or de-escalation radiation therapy 30Gy with concurrent cisplatin chemotherapy based on the results of FMISO PET Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group 3-4 months after completion of radiation therapy all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response
Researchers will assess the pathologic response rate after surgery in the de-escalation group They will also compare the outcomes oncological outcomes and quality of life between the group receiving the standard treatment 70Gy and the group receiving de-escalated radiation therapy 30Gy
Detailed Description:
This study is designed to evaluate the role of FMISO PET in selecting patients for de-escalated RT Patients with cT1-2N-1-2b HPV OPC or cTxN1-2 CUP who are suitable for surgical management of the primary if applicable andor RT to the primary and ipsilateral neck will be included All patients will undergo surgical resection or core biopsy of the primary site if applicable negative margins and robotic surgery not mandated or EUA and tonsillectomy CUP and FNA or core biopsy of the cervical lymph node all patients Patients will be eligible for inclusion if histopathology is consistent with HPV-associated squamous cell carcinoma or CUP with p16 positivity IHC and HPV positivity PCR
Patients enrolled will undergo FMISO PETCT after surgery to the primary or EUAbiopsy of suspected primary site to assess for tumour hypoxia which will stratify patients into two groups Determination for the presence or absence of hypoxia will be made on the basis of visual inspection and in accordance with well-established tumour-muscle activity ratio 12 on the late static 18F-FMISO PET by 1 nuclear medicine physician FMISO PET will be repeat after 5-10 fractions of RT 1-2 weeks of treatment with the same assessment for hypoxia
Absence of pre-treatment hypoxia or intra-treatment resolution of hypoxia on FMISO PET will be deemed as an indicator of radiosensitivity and qualify a patient for de-escalation ie to total dose 30Gy The remainder of patients ie with evidence of tumour hypoxia at the FMISO PET performed after 5-10 fractions of RT will continue to standard of care RT to a total dose of 70Gy
Additional MRI images including T1 T2 and dynamic contract-enhanced and oxygen enhanced sequences before and during RT at the same time as 18F FMISO PET These will not change the patients management
All patients will undergo routine FDG-PETCT scan three months after RT as part of standard of care Patients in the de-escalation arm will undergo mandatory ipsilateral neck dissection within 3-4 months of completing RT to assess for pathologic response Patients will be followed up for a minimum of five years post treatment
Patients enrolled will undergo FMISO PETCT after surgery to the primary or EUAbiopsy of suspected primary site to assess for tumour hypoxia which will stratify patients into two groups Determination for the presence or absence of hypoxia will be made on the basis of visual inspection and in accordance with well-established tumour-muscle activity ratio 12 on the late static 18F-FMISO PET by 1 nuclear medicine physician FMISO PET will be repeat after 5-10 fractions of RT 1-2 weeks of treatment with the same assessment for hypoxia
Absence of pre-treatment hypoxia or intra-treatment resolution of hypoxia on FMISO PET will be deemed as an indicator of radiosensitivity and qualify a patient for de-escalation ie to total dose 30Gy The remainder of patients ie with evidence of tumour hypoxia at the FMISO PET performed after 5-10 fractions of RT will continue to standard of care RT to a total dose of 70Gy
Additional MRI images including T1 T2 and dynamic contract-enhanced and oxygen enhanced sequences before and during RT at the same time as 18F FMISO PET These will not change the patients management
All patients will undergo routine FDG-PETCT scan three months after RT as part of standard of care Patients in the de-escalation arm will undergo mandatory ipsilateral neck dissection within 3-4 months of completing RT to assess for pathologic response Patients will be followed up for a minimum of five years post treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None