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

Oropharyngeal Cancer Clinical Trial

— FiGaRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953197
• Other study ID #: RJ113/N033
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Radiation:
• FDG-PET guided radiation dose escalation
Selective dose escalation

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Velindre NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year following completion of treatment in the last study participant