Status:
UNKNOWN
InGReS: Intra-treatment Image Guided Adaptive Radiotherapy Dose-escalation Study
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 feasibi...
Detailed Description
The study will recruit 15 patients with locally advanced oropharyngeal or hypopharyngeal squamous cell carcinoma (SCC) who are suitable for primary treatment with concurrent chemo-radiation. The main ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Locally advanced, histologically confirmed squamous cell carcinoma (SCC) of the oropharynx and hypopharynx to be treated with primary radical chemo-radiotherapy:
- Hypopharyngeal cancer - HPV negative OR HPV positive
- 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)
- ≥T2 tumours:
- Staging MRI showing minimum diameter of primary tumour greater than or equal to 1cm
- Staging 18F-FDG-PET/CT showing adequate uptake in the primary tumour, defined as SUVmax of ≥ 5.0
- Multidisciplinary team (MDT) decision to treat with primary CRT with curative intent
- Patients fit for radical treatment with primary CRT
- WHO Performance Status 0-1
- Exclusion criteria:
- Previous radiotherapy to the head and neck region interfering with the protocol treatment plan
- Patients requiring neo-adjuvant chemotherapy
- Inability to tolerate PET or MRI; general contra-indications to MRI
- Contra-indication to gadolinium
- Baseline SUVmax \< 5.0 in the primary tumour on PET-CT or smaller than 1cm in axial dimensions on cross sectional imaging
- GFR \<40ml/min
- 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).
Exclusion
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 16 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05393297
Start Date
June 17 2022
End Date
June 16 2025
Last Update
September 13 2023
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT