Adaptive radiotherapy dose escalation for head and neck cancer
InGReS: Intra-treatment Image Guided Adaptive Radiotherapy Dose-escalation Study
This study is testing if adjusting the radiation dose for patients with advanced head and neck cancer after two weeks of treatment can improve their outcomes while keeping side effects manageable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (London) |
| Trial ID | NCT05393297 on ClinicalTrials.gov |
What this trial studies
InGReS is a pilot study that investigates the feasibility of adaptive dose-escalated radiotherapy combined with platinum-based chemotherapy for patients with locally advanced head and neck cancer. The study involves assessing anatomical and metabolic changes in tumors using MRI and FDG-PET-CT scans after two weeks of standard treatment. Based on these imaging results, the radiotherapy plan will be adjusted to escalate the dose to the residual tumor during the final three weeks of treatment. The study aims to evaluate the safety, feasibility, and potential impact on treatment outcomes, particularly focusing on toxicity rates and long-term swallowing function.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced oropharyngeal or hypopharyngeal squamous cell carcinoma suitable for primary treatment with concurrent chemo-radiation.
Not a fit: Patients who have previously received radiotherapy to the head and neck region or those requiring neo-adjuvant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced toxicity for patients with head and neck cancer.
How similar studies have performed: Other studies have shown promise with adaptive radiotherapy approaches, but this specific dose-escalation strategy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Locally advanced, histologically confirmed squamous cell carcinoma (SCC) of the oropharynx and hypopharynx to be treated with primary radical chemo-radiotherapy: 1. Hypopharyngeal cancer - HPV negative OR HPV positive 2. Oropharyngeal cancer - EITHER HPV negative OR HPV positive with N stage at least N2b and greater than 10 pack year smoking history: All HPV positive oropharyngeal patients should have at least stage III disease (TNM8) 2. ≥T2 tumours: 3. Staging MRI showing minimum diameter of primary tumour greater than or equal to 1cm 4. Staging 18F-FDG-PET/CT showing adequate uptake in the primary tumour, defined as SUVmax of ≥ 5.0 5. Multidisciplinary team (MDT) decision to treat with primary CRT with curative intent 6. Patients fit for radical treatment with primary CRT 7. WHO Performance Status 0-1 Exclusion criteria: 1. Previous radiotherapy to the head and neck region interfering with the protocol treatment plan 2. Patients requiring neo-adjuvant chemotherapy 3. Inability to tolerate PET or MRI; general contra-indications to MRI 4. Contra-indication to gadolinium 5. Baseline SUVmax \< 5.0 in the primary tumour on PET-CT or smaller than 1cm in axial dimensions on cross sectional imaging 6. GFR \<40ml/min 7. Previous primary malignancy within 2 years (excluding adequately treated non-melanoma skin cancer, low risk Prostate cancer Gleason 6 or below, carcinoma in situ of cervix).
Where this trial is running
London
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Teresa Guerrero Urbano — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Smruti Gorsia
- Email: HeadandNeckResearchTeam@gstt.nhs.uk
- Phone: +44 (0)20 7188 2018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.