ARTFORCE PET Boost Study
Research type
Research Study
Full title
Dose-escalation by boosting radiation dose within the primary tumour on the basis of a pre-treatment FDG PET-CT scan (18F-deoxyglucose position emission tomography-CT scan)in stage IB, II and III non-small cell lung cancer: A randomised phase II trial.
IRAS ID
90203
Contact name
Corinne Faivre-Finn
Contact email
Sponsor organisation
NKI/AVL
Clinicaltrials.gov Identifier
Research summary
Lack of tumour control remains high in patients with stage IB, II and III non-small cell lung cancer after radiotherapy treatment with progression-free survival rates of about 30%. There is now strong evidence to suggest that improvements in local control will lead to improved survival. One of the strategies to improve local control is to increase the dose delivered to the tumour over a shorter amount of time.
In this study the dose of radiation to the tumour will be increased based on the patients FDG PET-CT scan. The vulnerable organs within the thorax (brachial plexus, spinal cord, heart, blood vessels and oesophagus) will receive a dose which is known to be manageable. This dose escalation will be individualised for each patient.
Patients will be treated with either high dose radiotherapy to the entire lung tumour (Arm A) or to the most FDG PET-CT active part of the tumour using a boost technique (Arm B) using state of the art radiotherapy techniques. Both treatment arms may be combined with chemotherapy (concurrent or sequential). The results of both treatments will then be compared.
Patients who have consented to take part in the study, but are unable to be randomised to Arm A or Arm B of the study due to dose constraints to organs at risk will still follow the treatment schedule, but without the boost technique and they will still be followed in the study.
A FDG PET-CT scan will be done shortly before the start of the radiotherapy treatment and will be repeated at 3 and 12 months after radiotherapy for assessment of treatment response. A radiotherapy treatment plan will be made and a random assignment will be carried out to determine which treatment will be given (Arm A or B). Radiotherapy will be given in 24 sessions over 5 weeks.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0835
Date of REC Opinion
28 Jan 2014
REC opinion
Further Information Favourable Opinion