18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours (FiGaRO)

August 27, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust

18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours (FiGaRO), A Phase 1 Pilot Study

Treatment of cancers of the head and neck, including oropharyngeal tumours, usually consist of a combination of radiotherapy and chemotherapy, although surgery may also play a part. Radiotherapy works by using the high energy x-rays to destroy cancer cells. Head and neck cancers often respond well to radiotherapy in the first instance and a proportion of patients will be cured by this treatment. However, not all of the cancer cells are destroyed by the combination of radiotherapy and chemotherapy and, in some patients, the cancer does come back.

Studies have suggested that more efficient killing of cancer cells, and therefore, better cure rates, can be achieved by increasing the radiotherapy dose. However, in the past, this was not possible due to side effects. Intensity Modulated Radiotherapy (IMRT) is a new radiotherapy delivery technique that allows better shaping of the dose to the areas that need irradiating with the potential for fewer side effects. If the investigators use IMRT to deliver an intentionally higher dose of radiation (called a boost) to small selected areas whilst, at the same time giving standard treatment doses to the remaining areas, this approach is called IMRT dose-painting. These selected areas can be identified by a scan called 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography, also known as a 'PET' scan) which is a type of scan that can give information about the activity of a cancer.

The purpose of this study is to find out whether the investigators can use IMRT dose-painting to boost the dose to the region inside a tumour which appears most active on 18F-FDG-PET. If this study shows that this approach is well-tolerated, then the investigators may be able to improve cure rates with this treatment. This would need to be tested in a subsequent study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma (SCC) of the oropharynx assessed as either HPV negative or HPV positive with greater than 10 pack year smoking history and N stage at least N2b, to be treated with primary radical neoadjuvant chemotherapy followed by chemo-intensity modulated radiotherapy (chemo-IMRT) to the primary and bilateral neck nodes
  • Age ≥ 18 years.
  • ≥T2 tumours.
  • Staging 18F-FDG-PET/CT showing adequate uptake at the level of the primary tumour.
  • WHO performance status 0-2.
  • Renal function adequate for cisplatin chemotherapy.
  • All patients must be suitable to attend regular follow-up.
  • Written informed consent must be obtained in all patients.

Exclusion Criteria:

  • Previous radiotherapy to the head and neck region interfering with the protocol treatment plan.
  • Previous malignancy except non-melanoma skin cancer.
  • Previous or concurrent illness, which in the investigators opinion, would interfere with either completion of therapy or follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm radiotherapy dose escalation
FDG-PET guided radiation dose escalation Selective dose escalation
Radiation: FDG-PET guided radiation dose escalation
Selective dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients suffering grade 3 or more late mucosal toxicity, assessed using the RTOG /EORTC and modified LENTSOMA scale, at one year post treatment
Time Frame: 1 year following completion of treatment in the last study participant
1 year following completion of treatment in the last study participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

Velindre NHS Trust

Investigators

  • Principal Investigator: Teresa Guerrero Urbano, Guy's & St Thomas' NHS Foundation Trust, London, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ113/N033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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