Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04242459
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2019-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
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:
INSIGHT-2
Brief Summary:
This is a non-randomised study to develop personalised treatment approaches in participants with Locally Advanced Head and Neck Cancer (HNC) of the oropharynx and base of skull by integrating the use of MR-guided Adaptive Radiotherapy (MRgRT) and functional image-guided radiotherapy (FIgRT).
The study is made up of two parts:
1. Feasibility planning study consisting of a total of 13 patients. This will include patients with either Human papilomavirus-associated (HPV-associated) oropharyngeal cancer (OPC), Human papilomavirus-negative (HPV-negative) OPC or Base of Skull HNC.
2. Single centre prospective interventional phase I/II study (main study) made up of 3 independent arms (on the condition of success of the feasibility stage).
1. Cohort 1: HPV-associated OPC consisting of 25 participants
2. Cohort 2: HPV-negative OPC consisting of a minimum of 10 patients and a maximum of 53 participants
3. Cohort 3: Base of Skull HNC consisting of 25 participants
The study is made up of two parts:
1. Feasibility planning study consisting of a total of 13 patients. This will include patients with either Human papilomavirus-associated (HPV-associated) oropharyngeal cancer (OPC), Human papilomavirus-negative (HPV-negative) OPC or Base of Skull HNC.
2. Single centre prospective interventional phase I/II study (main study) made up of 3 independent arms (on the condition of success of the feasibility stage).
1. Cohort 1: HPV-associated OPC consisting of 25 participants
2. Cohort 2: HPV-negative OPC consisting of a minimum of 10 patients and a maximum of 53 participants
3. Cohort 3: Base of Skull HNC consisting of 25 participants
Detailed Description:
This study is looking at improving radiotherapy treatment for head and neck cancers by:
1. Repeating the radiotherapy planning scan at weeks 2 and 4 of treatment so that investigators can adapt the radiotherapy to changes to the shape of the cancer and the patient's body. These changes can affect the accuracy and the radiotherapy doses delivered.
2. Using a MR (magnetic resonance) scans to view and target the cancer with more precision.
3. Identifying HPV negative oropharyngeal cancer who are non-responders and increasing the radiotherapy dose.
The 3 groups of patients are:
1. Cancers of the oropharynx (middle of the throat) that test positive for HPV (human papilloma virus). If HPV is present, the cancer responds better to treatment and there is a higher chance of cure. In this group, the investigators aim is to reduce radiotherapy associated long-term side effects by sparing healthy tissue from high doses.
2. If the oropharyngeal cancers test negative for HPV, they are less likely to respond well to treatment. The investigator's department has shown that investigators can predict which patients will respond to treatment using a special type of MR scan. Investigators will increase the dose of radiotherapy to HPV negative patients who are predicted to be non-responders with the aim of improving the chance of cure.
3. Cancers that located at the base of the skull are not seen very well on CT scan. By using MR imaging, investigators can visualize the surrounding normal organs and the cancer better, target the cancer with more precision and adapt to changes to the healthy organs and tumour.
Investigators will also test if they can predict response to treatment by checking blood for fragments of the cancer and using a special MRI.
The study will be conducted at the Royal Marsden in Sutton only and will be followed up for 2 years.
1. Repeating the radiotherapy planning scan at weeks 2 and 4 of treatment so that investigators can adapt the radiotherapy to changes to the shape of the cancer and the patient's body. These changes can affect the accuracy and the radiotherapy doses delivered.
2. Using a MR (magnetic resonance) scans to view and target the cancer with more precision.
3. Identifying HPV negative oropharyngeal cancer who are non-responders and increasing the radiotherapy dose.
The 3 groups of patients are:
1. Cancers of the oropharynx (middle of the throat) that test positive for HPV (human papilloma virus). If HPV is present, the cancer responds better to treatment and there is a higher chance of cure. In this group, the investigators aim is to reduce radiotherapy associated long-term side effects by sparing healthy tissue from high doses.
2. If the oropharyngeal cancers test negative for HPV, they are less likely to respond well to treatment. The investigator's department has shown that investigators can predict which patients will respond to treatment using a special type of MR scan. Investigators will increase the dose of radiotherapy to HPV negative patients who are predicted to be non-responders with the aim of improving the chance of cure.
3. Cancers that located at the base of the skull are not seen very well on CT scan. By using MR imaging, investigators can visualize the surrounding normal organs and the cancer better, target the cancer with more precision and adapt to changes to the healthy organs and tumour.
Investigators will also test if they can predict response to treatment by checking blood for fragments of the cancer and using a special MRI.
The study will be conducted at the Royal Marsden in Sutton only and will be followed up for 2 years.
Study Oversight
Has Oversight DMC:
True
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?: