Clinical trial · Interventional
InGReS: Intra-treatment Image Guided Adaptive Radiotherapy Dose-escalation Study
- 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)
InGReS is a phase I pilot study of adaptive dose-escalated radiotherapy in combination with platinum-based chemotherapy (CRT) for locally advanced head and neck cancer. InGReS will assess the feasibility of adapting the radiotherapy (RT) plan for each patient, based on anatomical and metabolic changes in the tumour seen on MRI and FDG-PET-CT performed after 2 weeks of CRT in a multicentre setting. The overall aim of the trial is to determine the safety and feasibility of delivering dose-escalated Intensity Modulated Radiotherapy (IMRT) to the residual primary tumour, as seen on intra-treatment imaging, in the final 3 weeks of RT.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging: Intra-treatment FDG-PET-CT and MRI | Diagnostic Test | — | UNRESOLVED |
| Intra-treatment Image-Guided Adaptive Radiotherapy Dose-escalation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HNSCC receiving (chemo)radiotherapy
- description
- Radiation: Intra-treatment FDG-PET-CT and MRI will be used to identify tumours and patients for dose-escalation. Patients identified for dose-escalation (boost) will undergo adaptive radiotherapy replanning, with the primary tumour (GTVp) receiving 76.9Gy in 35 fractions.
- interventionNames
- Diagnostic Test: Imaging: Intra-treatment FDG-PET-CT and MRI
- Radiation: Intra-treatment Image-Guided Adaptive Radiotherapy Dose-escalation
Primary outcomes (1)
- measure
- To assess the safety of delivering an additional 10% dose (biological rather than numerical) of radiotherapy to the residual primary tumour during radiotherapy
- timeFrame
- 12 months
- description
- Incidence of grade 3 or above late Radiation Therapy Oncology Group (RTOG) and European Organization for Research and Treatment of Cancer (EORTC) mucosal toxicity or feeding tube retention rate following completion of treatment. An excess rate of \>14% would be regarded as unacceptable.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available