Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers
-
- STATUS
- Recruiting
-
- participants needed
- 73
-
- sponsor
- Royal Marsden NHS Foundation Trust
Summary
This is a non-randomised study to develop personalised treatment approaches in participants
with Locally Advanced
The study is made up of two parts:
- 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. - 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).
- Cohort 1: HPV-associated OPC consisting of 25 participants
- Cohort 2: HPV-negative OPC consisting of a minimum of 10 patients and a maximum of 53 participants
- Cohort 3: Base of Skull HNC consisting of 25 participants
Description
This study is looking at improving
- Repeating the
radiotherapy planningscan at weeks 2 and 4 of treatment so that investigators can adapt theradiotherapy to changes to the shape of thecancer and the patient's body. These changes can affect the accuracy and theradiotherapy doses delivered. - Using a MR (
magnetic resonance ) scans to view and target thecancer with more precision. - Identifying HPV negative
oropharyngeal cancer who are non-responders and increasing theradiotherapy dose.
The 3 groups of patients are:
Cancers of the oropharynx (middle of thethroat ) that test positive for HPV (humanpapilloma virus). If HPV is present, thecancer responds better to treatment and there is a higher chance of cure. In this group, the investigators aim is to reduceradiotherapy associated long-term side effects by sparing healthy tissue from high doses.- 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 MRscan . Investigators will increase the dose ofradiotherapy to HPV negative patients who are predicted to be non-responders with the aim of improving the chance of cure. Cancers that located at the base of the skull are not seen very well onCT scan . By usingMR imaging , investigators can visualize the surrounding normal organs and thecancer better, target thecancer with more precision and adapt to changes to the healthy organs andtumour .
Investigators will also test if they can predict response to treatment by checking blood for
fragments of the
The study will be conducted at the Royal Marsden in Sutton only and will be followed up for 2 years.
Details
Condition |
|
---|---|
Age | 18years - 70years |
Treatment |
Adaptive |
Clinical Study Identifier | NCT04242459 |
Sponsor | Royal Marsden NHS Foundation Trust |
Last Modified on | 19 February 2024 |
How to participate?
,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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