Clinical trial · Interventional
Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Feasibility Study
- 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.
- type
- EXPERIMENTAL
- label
- HPV associated OPC Participants
- 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.
- interventionNames
- Radiation: Adaptive Radiotherapy
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available