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Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers (INSIGHT-2)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Adaptive Radiotherapy
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Cancer, Oropharynx, HPV, Base of Skull

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Feasibility study and Main Study:

  • Participants with stage III/IV ((American Joint Committee (AJC) Tumour, Nodes, Metastasis (TMN) on Cancer Version 7)) head and neck cancer planned for primary radical chemo-radiotherapy OR induction chemotherapy followed by chemoradiotherapy with concomitant platinum-based chemotherapy.
  • Age between 18 and 70 years.
  • Participant can provide informed consent.
  • World Health Organisation (WHO) performance status 0 - 1.
  • Creatinine Clearance >50ml/minute
  • Absolute Neutrophil Count ≥1.5 x10^9/L
  • Platelets ≥100 x10^9/L
  • Haemoglobin ≥90g/L

Feasibility Study:

- Participants with either HPV associated OPC, HPV negative OPC or Base of Skull HNC.

Low Risk HPV associated OPC:

  • T1-3, N0-2c (AJCC 7th Edition, stage III and above)
  • Participants with histologically proven squamous cell carcinoma of the head and neck
  • p16 positive (defined as >70% cells staining positive)
  • <10 year pack smoking history

HPV Associated OPC:

  • Patients with histologically proven squamous cell carcinoma of the head and neck
  • T1-3,N0-2c (AJCC 7th Edition, stage III and above) with ≥10 pack/ year smoking history
  • p16 positive
  • Any T4 and/or N3 regardless of smoking history
  • Primary tumour size </=5cm

HPV negative OPC, hypopharyngeal or laryngeal cancer:

  • Patients with histologically proven squamous cell carcinoma of the head and neck
  • T1-4,N0-3 (AJCC 7th edition, stage III and above)
  • p16 negative (if OPC)
  • Primary tumour size </=5cm

Base of skull Head and Neck Cancer:

- Participants with histologically proven squamous cell carcinoma or undifferentiated carcinoma of the head and neck (sinonasal and nasopharynx)

Exclusion Criteria:

  • WHO performance status >=2.
  • Participants with any previous malignancy except non-melanoma skin cancer.
  • Participants with prior radiotherapy to the head and neck region
  • Participants with contraindications to MRI scan.
  • Participants with contraindications to IV contrast agents.
  • Participants with renal failure

Sites / Locations

  • Head and Neck Unit, Royal Marsden HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Feasibility Study

HPV associated OPC Participants

HPV negative OPC Participants - Radiotherapy dose escalation

Base of Skull HNC Participants

Arm Description

This is a radiotherapy planning study to evaluate the feasibility to acquire longitudinal MRI scans during radiotherapy (prior to the main study) thus, participants will receive standard-of-care chemoradiation therapy (CRT) as per departmental protocol without any treatment adaptation.

Participants will be treated initially with the standard radiotherapy dose of: 65 grays (Gy) in 30 fractions (2.17Gy per fraction) over 6 weeks to the primary and nodal tumour. 54Gy in 30 fractions (1.8Gy per fraction) over 6 weeks to the nodal areas at risk of harbouring microscopic disease In the 2nd week and 4th week of treatment, the participants will undergo Adaptive Radiotherapy to account for anatomical changes.

Participants will be treated initially with the standard radiotherapy dose of: 65Gy in 30 fractions (2.17Gy per fraction) over 6 weeks to the primary and nodal tumour. 54Gy in 30 fractions (1.8Gy per fraction) over 6 weeks to the nodal areas at risk of harbouring microscopic disease After 10 fractions the participants will be stratified into either "responders" or "non-responders" categories based on Apparent Diffusion Coefficients (ADC) response at week 2 of CRT. Participants classified as "responders" will complete treatment without any radiotherapy dose changes. Their radiotherapy treatment target volumes will be adapted at weeks 2 and 4 of CRT to account for volume changes to the tumour. The "non-responders" will undergo an increase in dose per fraction to Clinical Target Volume-1 (CTV-1) primary for fractions 11 to 30.

Participants will be treated initially with the standard radiotherapy dose of: 65Gy in 30 fractions (2.17Gy per fraction) over 6 weeks to the primary and nodal tumour. 54Gy in 30 fractions (1.8Gy per fraction) over 6 weeks to the nodal areas at risk of harbouring microscopic disease Participants will undergo standard treatment with 3 cycles of induction chemotherapy followed by chemo-radiotherapy dose. Their radiotherapy treatment will be adapted at weeks 2 and 4 of CRT to account for volume changes to the tumour.

Outcomes

Primary Outcome Measures

Assess the feasibility of participants undergoing MR scan at baseline, week 2 and week 4 and feasibility of producing an adaptive radiotherapy plan
To calculate the proportion of participants who have successfully undergone the planned MRI scan at baseline and weeks 2 and 4 to determine the feasibility of producing an adaptive radiotherapy plan in the feasibility study.
Compare the mean cumulative radiotherapy doses Main Study, Cohort 1: Compare the mean cumulative radiotherapy doses received by the parotid gland in an adaptive plan at weeks 3 and 5 to a non-adaptive plan
To determine the radiotherapy dose delivered to the parotid gland through adaptive radiotherapy volume adaptation planning compared to a non-adaptive radiotherapy approach in the main study, cohort 1.
Assess the safety of radiotherapy dose escalation by measuring the grades of acute radiation induced toxicities using NCI CTCAE v5.0 scores at 3 months
To assess the safety of radiotherapy dose escalation by measuring the grades of acute radiation induced toxicities which will be assessed using the NCI CTCAE v5.0 scores at 3 months in the main study, cohort 2.
Determine the Maximum Tolerated Dose (MTD) of the escalated radiotherapy dose as per the dose escalation criteria and stopping rules set out in the protocol
To determine the MTD of the escalated radiotherapy dose in the main study as per the dose escalation criteria and stopping rules as outlined in the protocol in the main study, cohort 2.
Compare the radiotherapy doses to the parotid glands calculated and recorded at baseline with doses from the adaptive plan at weeks 3 and 5
To calculate and record radiotherapy doses to the parotid glands at baseline and compare these to doses from the adaptive plan at weeks 3 and 5 in the main study, cohort 3.

Secondary Outcome Measures

Calculate the proportion of patients who investigators can successfully produce an adaptive radiotherapy plan at weeks 3 and 5 within 1 week of their rescan to account for anatomical changes.
To calculate the proportion of patients who investigators can successfully produce an adaptive radiotherapy plan at weeks 3 and 5 within 1 week of their rescan to account for anatomical changes. To calculate whether investigators can create an adaptive radiotherapy plan at weeks 3 and 5.
Calculate participants complete response rate at 3 months which is defined as no clinically visible, palpable or measurable disease on imaging or no residual tumour on neck dissection or directed biopsy
To calculate the complete response rate of participants at 3 months in the main study, cohorts 1-3. Response rate is defined as no clinically visible, palpable or measurable disease on imaging (PET-CT and/or MRI) or no residual tumour on neck dissection or directed biopsy.
Calculate the progression free survival which is defined as the time from entry into the study until disease progression or death (days)
To calculate the progression free survival which is defined as the time from entry into the study until disease progression or death in the main study, cohorts 1-3. This will be measured in whole days.
Calculate the disease specific survival which is defined as the time from entry into the study until death from any cause (days)
Calculate the disease specific survival which is defined as the time from entry into the study until death from any cause in the main study, cohorts 1-3. This will be measured in whole days.
Assess quality of life using the EORTC Quality of Life Questionnaire (QLQ) C30 version 3.0 with the associated Head and Neck module (HN35)
Assess quality of life using the EORTC Quality of Life Questionnaire (QLQ) C30 version 3.0 with the associated Head and Neck module (HN35) in the main study, cohorts 1-3.
Assess late radiation induced toxicities which will be recorded using the late effects in normal tissues subjective, objective, management and analytic scales (LENT SOMA) score and NCI CTCAE v5.0 late radiotherapy scoring systems.
To assess late radiation induced toxicities which will be recorded using the LENT SOMA score and NCI CTCAE v5.0 late radiotherapy scoring systems. The incidence and prevalence (highest grades) of late side effects of radiotherapy will be reported in the main study, cohorts 1-3.
Calculate the duration of acute radiation induced toxicities will be assessed using the NCI CTCAE v5.0 score (HPV associated OPC and skull base tumours); All participants will be evaluated assess xerostomia, mucositis, dysphagia and dermatitis
To calculate the duration of acute radiation induced toxicities will be assessed using the NCI CTCAE v5.0 score (HPV associated OPC and skull base tumours); All participants will be evaluated using the NCI CTCAE v5.0 score to assess xerostomia, mucositis, dysphagia and dermatitis in the main study, cohorts 1-3.
Assess the Incidence of feeding tube dependency at one year (HPV negative) which is defined as participant needing supplementation of nutrition by feeding tube.
To assess the Incidence of feeding tube dependency at one year (HPV negative) which is defined as participant needing supplementation of nutrition by feeding tube In the main study, cohorts 1-3.
Calculate the mean radiotherapy doses to the organs at risk (spinal cord, optic chiasm and brainstem) and target volume will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5.
To calculate the mean radiotherapy doses to the organs at risk (spinal cord, optic chiasm and brainstem) and target volume will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5 in the main study, cohort 3.
Calculate the mean radiotherapy doses to the organs at risk (salivary gland, spinal cord and brainstem) will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5.
To calculate the mean radiotherapy doses to the organs at risk (salivary gland, spinal cord and brainstem) will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5 in the main study, cohort 1.

Full Information

First Posted
November 8, 2019
Last Updated
July 21, 2021
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04242459
Brief Title
Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers
Acronym
INSIGHT-2
Official Title
Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

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
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: 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
Detailed Description
This study is looking at improving radiotherapy treatment for head and neck cancers by: 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. Using a MR (magnetic resonance) scans to view and target the cancer with more precision. Identifying HPV negative oropharyngeal cancer who are non-responders and increasing the radiotherapy dose. The 3 groups of patients are: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Cancer, Oropharynx, HPV, Base of Skull

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study will commence with a Feasibility Radiotherapy planning CT study consisting of 13 participants, then will recruit to the the main phase I/II interventional study consisting of 3 independent cohorts.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feasibility Study
Arm Type
No Intervention
Arm Description
This is a radiotherapy planning study to evaluate the feasibility to acquire longitudinal MRI scans during radiotherapy (prior to the main study) thus, participants will receive standard-of-care chemoradiation therapy (CRT) as per departmental protocol without any treatment adaptation.
Arm Title
HPV associated OPC Participants
Arm Type
Experimental
Arm Description
Participants will be treated initially with the standard radiotherapy dose of: 65 grays (Gy) in 30 fractions (2.17Gy per fraction) over 6 weeks to the primary and nodal tumour. 54Gy in 30 fractions (1.8Gy per fraction) over 6 weeks to the nodal areas at risk of harbouring microscopic disease In the 2nd week and 4th week of treatment, the participants will undergo Adaptive Radiotherapy to account for anatomical changes.
Arm Title
HPV negative OPC Participants - Radiotherapy dose escalation
Arm Type
Experimental
Arm Description
Participants will be treated initially with the standard radiotherapy dose of: 65Gy in 30 fractions (2.17Gy per fraction) over 6 weeks to the primary and nodal tumour. 54Gy in 30 fractions (1.8Gy per fraction) over 6 weeks to the nodal areas at risk of harbouring microscopic disease After 10 fractions the participants will be stratified into either "responders" or "non-responders" categories based on Apparent Diffusion Coefficients (ADC) response at week 2 of CRT. Participants classified as "responders" will complete treatment without any radiotherapy dose changes. Their radiotherapy treatment target volumes will be adapted at weeks 2 and 4 of CRT to account for volume changes to the tumour. The "non-responders" will undergo an increase in dose per fraction to Clinical Target Volume-1 (CTV-1) primary for fractions 11 to 30.
Arm Title
Base of Skull HNC Participants
Arm Type
Experimental
Arm Description
Participants will be treated initially with the standard radiotherapy dose of: 65Gy in 30 fractions (2.17Gy per fraction) over 6 weeks to the primary and nodal tumour. 54Gy in 30 fractions (1.8Gy per fraction) over 6 weeks to the nodal areas at risk of harbouring microscopic disease Participants will undergo standard treatment with 3 cycles of induction chemotherapy followed by chemo-radiotherapy dose. Their radiotherapy treatment will be adapted at weeks 2 and 4 of CRT to account for volume changes to the tumour.
Intervention Type
Radiation
Intervention Name(s)
Adaptive Radiotherapy
Intervention Description
Determining the radiotherapy dose delivered to organs at risk (OAR) or to the target volume (dependent on what arm the participant is assigned to) through adaptive radiotherapy volume adaption planning
Primary Outcome Measure Information:
Title
Assess the feasibility of participants undergoing MR scan at baseline, week 2 and week 4 and feasibility of producing an adaptive radiotherapy plan
Description
To calculate the proportion of participants who have successfully undergone the planned MRI scan at baseline and weeks 2 and 4 to determine the feasibility of producing an adaptive radiotherapy plan in the feasibility study.
Time Frame
Through feasibility study completion, estimated 6 months.
Title
Compare the mean cumulative radiotherapy doses Main Study, Cohort 1: Compare the mean cumulative radiotherapy doses received by the parotid gland in an adaptive plan at weeks 3 and 5 to a non-adaptive plan
Description
To determine the radiotherapy dose delivered to the parotid gland through adaptive radiotherapy volume adaptation planning compared to a non-adaptive radiotherapy approach in the main study, cohort 1.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Assess the safety of radiotherapy dose escalation by measuring the grades of acute radiation induced toxicities using NCI CTCAE v5.0 scores at 3 months
Description
To assess the safety of radiotherapy dose escalation by measuring the grades of acute radiation induced toxicities which will be assessed using the NCI CTCAE v5.0 scores at 3 months in the main study, cohort 2.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Determine the Maximum Tolerated Dose (MTD) of the escalated radiotherapy dose as per the dose escalation criteria and stopping rules set out in the protocol
Description
To determine the MTD of the escalated radiotherapy dose in the main study as per the dose escalation criteria and stopping rules as outlined in the protocol in the main study, cohort 2.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Compare the radiotherapy doses to the parotid glands calculated and recorded at baseline with doses from the adaptive plan at weeks 3 and 5
Description
To calculate and record radiotherapy doses to the parotid glands at baseline and compare these to doses from the adaptive plan at weeks 3 and 5 in the main study, cohort 3.
Time Frame
Through main study treatment period, estimated 5 years.
Secondary Outcome Measure Information:
Title
Calculate the proportion of patients who investigators can successfully produce an adaptive radiotherapy plan at weeks 3 and 5 within 1 week of their rescan to account for anatomical changes.
Description
To calculate the proportion of patients who investigators can successfully produce an adaptive radiotherapy plan at weeks 3 and 5 within 1 week of their rescan to account for anatomical changes. To calculate whether investigators can create an adaptive radiotherapy plan at weeks 3 and 5.
Time Frame
Through feasibility study completion, estimated 6 months.
Title
Calculate participants complete response rate at 3 months which is defined as no clinically visible, palpable or measurable disease on imaging or no residual tumour on neck dissection or directed biopsy
Description
To calculate the complete response rate of participants at 3 months in the main study, cohorts 1-3. Response rate is defined as no clinically visible, palpable or measurable disease on imaging (PET-CT and/or MRI) or no residual tumour on neck dissection or directed biopsy.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Calculate the progression free survival which is defined as the time from entry into the study until disease progression or death (days)
Description
To calculate the progression free survival which is defined as the time from entry into the study until disease progression or death in the main study, cohorts 1-3. This will be measured in whole days.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Calculate the disease specific survival which is defined as the time from entry into the study until death from any cause (days)
Description
Calculate the disease specific survival which is defined as the time from entry into the study until death from any cause in the main study, cohorts 1-3. This will be measured in whole days.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Assess quality of life using the EORTC Quality of Life Questionnaire (QLQ) C30 version 3.0 with the associated Head and Neck module (HN35)
Description
Assess quality of life using the EORTC Quality of Life Questionnaire (QLQ) C30 version 3.0 with the associated Head and Neck module (HN35) in the main study, cohorts 1-3.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Assess late radiation induced toxicities which will be recorded using the late effects in normal tissues subjective, objective, management and analytic scales (LENT SOMA) score and NCI CTCAE v5.0 late radiotherapy scoring systems.
Description
To assess late radiation induced toxicities which will be recorded using the LENT SOMA score and NCI CTCAE v5.0 late radiotherapy scoring systems. The incidence and prevalence (highest grades) of late side effects of radiotherapy will be reported in the main study, cohorts 1-3.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Calculate the duration of acute radiation induced toxicities will be assessed using the NCI CTCAE v5.0 score (HPV associated OPC and skull base tumours); All participants will be evaluated assess xerostomia, mucositis, dysphagia and dermatitis
Description
To calculate the duration of acute radiation induced toxicities will be assessed using the NCI CTCAE v5.0 score (HPV associated OPC and skull base tumours); All participants will be evaluated using the NCI CTCAE v5.0 score to assess xerostomia, mucositis, dysphagia and dermatitis in the main study, cohorts 1-3.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Assess the Incidence of feeding tube dependency at one year (HPV negative) which is defined as participant needing supplementation of nutrition by feeding tube.
Description
To assess the Incidence of feeding tube dependency at one year (HPV negative) which is defined as participant needing supplementation of nutrition by feeding tube In the main study, cohorts 1-3.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Calculate the mean radiotherapy doses to the organs at risk (spinal cord, optic chiasm and brainstem) and target volume will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5.
Description
To calculate the mean radiotherapy doses to the organs at risk (spinal cord, optic chiasm and brainstem) and target volume will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5 in the main study, cohort 3.
Time Frame
Through main study treatment period, estimated 5 years.
Title
Calculate the mean radiotherapy doses to the organs at risk (salivary gland, spinal cord and brainstem) will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5.
Description
To calculate the mean radiotherapy doses to the organs at risk (salivary gland, spinal cord and brainstem) will be calculated and recorded at baseline and compared to doses from the adaptive plan at weeks 3 and 5 in the main study, cohort 1.
Time Frame
Through main study treatment period, estimated 5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Feasibility study and Main Study: Participants with stage III/IV ((American Joint Committee (AJC) Tumour, Nodes, Metastasis (TMN) on Cancer Version 7)) head and neck cancer planned for primary radical chemo-radiotherapy OR induction chemotherapy followed by chemoradiotherapy with concomitant platinum-based chemotherapy. Age between 18 and 70 years. Participant can provide informed consent. World Health Organisation (WHO) performance status 0 - 1. Creatinine Clearance >50ml/minute Absolute Neutrophil Count ≥1.5 x10^9/L Platelets ≥100 x10^9/L Haemoglobin ≥90g/L Feasibility Study: - Participants with either HPV associated OPC, HPV negative OPC or Base of Skull HNC. Low Risk HPV associated OPC: T1-3, N0-2c (AJCC 7th Edition, stage III and above) Participants with histologically proven squamous cell carcinoma of the head and neck p16 positive (defined as >70% cells staining positive) <10 year pack smoking history HPV Associated OPC: Patients with histologically proven squamous cell carcinoma of the head and neck T1-3,N0-2c (AJCC 7th Edition, stage III and above) with ≥10 pack/ year smoking history p16 positive Any T4 and/or N3 regardless of smoking history Primary tumour size </=5cm HPV negative OPC, hypopharyngeal or laryngeal cancer: Patients with histologically proven squamous cell carcinoma of the head and neck T1-4,N0-3 (AJCC 7th edition, stage III and above) p16 negative (if OPC) Primary tumour size </=5cm Base of skull Head and Neck Cancer: - Participants with histologically proven squamous cell carcinoma or undifferentiated carcinoma of the head and neck (sinonasal and nasopharynx) Exclusion Criteria: WHO performance status >=2. Participants with any previous malignancy except non-melanoma skin cancer. Participants with prior radiotherapy to the head and neck region Participants with contraindications to MRI scan. Participants with contraindications to IV contrast agents. Participants with renal failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abi Temple
Phone
020 8661 3561
Ext
4020
Email
abigail.temple@rmh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Scott
Phone
020 8661 3561
Ext
4020
Email
amy.scott@rmh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kee H. Wong, MD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Head and Neck Unit, Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abi Temple
Phone
0208 661 3561
Ext
4020
Email
abigail.temple@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Amy Scott
Phone
0208 661 3561
Ext
4020
Email
amy.scott@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Shreerang Bhide, MD
First Name & Middle Initial & Last Name & Degree
Kevin Harrington, MD
First Name & Middle Initial & Last Name & Degree
Christopher Nutting, MD
First Name & Middle Initial & Last Name & Degree
Kate Newbold, MD
First Name & Middle Initial & Last Name & Degree
Maria Schmidt, MD
First Name & Middle Initial & Last Name & Degree
Dow-Mu Koh, MD
First Name & Middle Initial & Last Name & Degree
Yong Du, MD
First Name & Middle Initial & Last Name & Degree
Derfel Ap Dafydd, MD
First Name & Middle Initial & Last Name & Degree
Alex Dunlop, MD
First Name & Middle Initial & Last Name & Degree
Dualta McQuaid, MD
First Name & Middle Initial & Last Name & Degree
Oliver Gurney-Champion, MD
First Name & Middle Initial & Last Name & Degree
Martin Leach, MD
First Name & Middle Initial & Last Name & Degree
Sarah Gulliford, MD
First Name & Middle Initial & Last Name & Degree
Brian Ng-Cheng-Hin, MD
First Name & Middle Initial & Last Name & Degree
Kee H. Wong, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers

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