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

NCT05393297 | Unknown

• 2 other identifiers: 22/LO/0056257601
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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

Head and Neck Cancer

Keywords

Radiotherapy; Adaptive; Dose-escalation; Oropharyngeal Squamous Cell Carcinoma; Hypopharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• To assess the safety of delivering an additional 10% dose (biological rather than numerical) of radiotherapy to the residual primary tumour during radiotherapy

  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.

  12 months

Secondary Outcomes (13)

• Incidence of grade 4 acute mucosal toxicity (NCI CTCAE)

  12 weeks

• Incidence of grade 3 or above late non-mucosal toxicity (NCI CTCAE)

  12 months

• Incidence of grade 3 or above late non-mucosal toxicity (RTOG/EORTC)

  12 months

• Incidence of grade 3 or above late non-mucosal toxicity (LENT/SOMA criteria)

  12 months

• To assess swallowing panel measurements including qualitative swallowing assessments (MDADI)

  12 months

Study Arms (1)

HNSCC receiving (chemo)radiotherapy

EXPERIMENTAL

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.

Diagnostic Test: Imaging: Intra-treatment FDG-PET-CT and MRI; Radiation: Intra-treatment Image-Guided Adaptive Radiotherapy Dose-escalation

Interventions

Imaging: Intra-treatment FDG-PET-CT and MRI DIAGNOSTIC_TEST

FDG-PET-CT and MRI scan will be used during radiotherapy to assess early treatment response and identify tumours eligible for dose-escalation.

HNSCC receiving (chemo)radiotherapy

Intra-treatment Image-Guided Adaptive Radiotherapy Dose-escalation RADIATION

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

HNSCC receiving (chemo)radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Teresa Guerrero Urbano

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smruti Gorsia

CONTACT

+44 (0)20 7188 2018; HeadandNeckResearchTeam@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Oncologist

Model Details: Feasibility study

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 26, 2022
• Study Start: June 17, 2022
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)