Clinical Trial: 18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours (FiGaRO), A Phase 1 Pilot Study
Brief Summary:
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.
Detailed Summary:
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Guy's and St Thomas' NHS Foundation Trust
Dates:
Date Received: October 25, 2016
Date Started: February 2013
Date Completion: October 2018
Last Updated: October 31, 2016
Last Verified: October 2016
