NCT05393297

InGReS: Intra-treatment Image Guided Adaptive Radiotherapy Dose-escalation Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 aim is to see whether it is feasible to perform a FDG positron emission tomography-computed tomography (FDG-PET-CT) and Magnetic Resonance Imaging (MRI) scan after 2 weeks of radiotherapy and re-plan the radiotherapy to escalate the dose of radiotherapy delivered to the residual primary tumour as seen on PET-CT and MRI. Patients will commence with standard chemo-radiotherapy; 70 Gray (Gy) in 35 fractions with concomitant platinum chemotherapy. After 2 weeks of chemo-radiotherapy patients will have an intra-treatment FDG-PET-CT and MRI scan to assess early response to treatment. Patients with evidence of residual disease will proceed with the dose-escalation phase of the study, with an adaptive radiotherapy re-plan and dose-escalation to the residual primary tumour. The study will establish acute and late radiotherapy toxicity rates in patients who receive dose-escalated RT, particularly the effect of treatment on long-term swallowing function. The study hypothesis is that mucosal toxicity rates for dose-escalated treatment will be equivalent to those for standard CRT, according to published data. Furthermore, it will also explore whether changes in FDG-PET-CT and MRI during treatment correlate with patient outcomes and potential blood-based biomarkers of treatment response. Local control, disease-free and overall survival will be assessed for both standard and dose-escalated approaches.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Imaging: Intra-treatment FDG-PET-CT and MRI	FDG-PET-CT and MRI scan will be used during radiotherapy to assess early treatment response and identify tumours eligible for dose-escalation.
RADIATION	Intra-treatment Image-Guided Adaptive Radiotherapy Dose-escalation	Tumours eligible for dose-escalation (boost), as seen on intra-treatment FDG-PET-CT and MRI scan, will receive 76.9 Gy to the residual gross primary tumour. The radiotherapy plan will be replanned to incorporate the simultaneous-integrated-boost to the GTVp which will be delivered over the last 3 weeks of treatment

Timeline

• Start date: 2022-06-17
• Primary completion: 2024-06-16
• Completion: 2025-06-16
• First posted: 2022-05-26
• Last updated: 2023-09-13

Locations

1 site across 1 country: United Kingdom