Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT04242459
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04242459
Study Brief:
Protocol Section:
NCT04242459