Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
NCT ID: NCT01836692
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2014-04-30
2018-06-30
Brief Summary
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In this study, we will investigate:
* whether giving a more targeted and individualised type of chest irradiation or radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it causes side effects which can be tolerated
* whether this new method of delivering the radiotherapy can reduce the risk of the tumour in the lung recurring or progressing
* whether survival can be improved by using this new radiotherapy method
The dose of chest irradiation will be calculated specifically to suit patient's body shape, the position of the lung cancer, and how close healthy tissues are to the tumour. Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration of treatment will vary individually according to the delivered dose to the tumour area.
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Detailed Description
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Approximately 12,000 patients are diagnosed with stage III NSCLC in the UK each year and their survival is \~15% at 5 years. As the majority of patients are not suitable for the gold standard treatment (concurrent chemo-radiotherapy (CTRT), novel strategies integrating radiotherapy (RT) technological advances and radiobiological knowledge need to be evaluated in patients treated with the alternative treatment option, sequential CTRT. There is solid evidence that improving local control in lung cancer leads to increased survival. Strategies to improve local control in stage III NSCLC include dose escalation and individualisation which are limited by the dose delivered to surrounding normal tissues. We hypothesise that this will be facilitated by the use of IMRT.
Objectives:
To demonstrate the feasibility of delivering isotoxic RT using IMRT and hyperfractionated accelerated RT in stage III NSCLC patients who are not suitable for concurrent CTRT.
Endpoints:
Primary endpoint: Delivery of isotoxic IMRT to dose \>60 Gy EQD2 (total biologically equivalent in 2 Gy fraction).
Secondary endpoints: Estimation of the suitability for lung isotoxic IMRT, estimation of proportion of patients with acute grade 3+ non haematological toxicity, estimation of late toxicity, estimation of local control/overall survival and development of a robust Quality Assurance (QA) process for lung IMRT.
Design:
Prospective multicentre, non-randomised feasibility study with early stopping rules.
35 patients will be recruited in this prospective multicentre feasibility study. Stopping rules are in place to ensure the safety of patients. We estimate that this regimen would be of added value to a national randomised phase II trial if 80% of the patients can be planned to a dose \>60 Gy EQD2.
Intervention:
Patients with stage III NSCLC, PS 0-2, not suitable for concurrent CTRT, will be treated with individualised doses of radiation based on pre-specified normal tissue doses (spinal cord, brachial plexus, lung tissue, heart and great vessels/proximal bronchial tree). Radiotherapy will be delivered twice-daily over a maximum period of 4.5 weeks using IMRT and the dose of radiation will be increased until one or more of the organs at risk tolerance or the maximum dose of 79.2 Gy is reached.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thoracic radiotherapy
Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks)
Intensity Modulated Radiotherapy treatment
Intensity Modulated Radiotherapy treatment
Interventions
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Intensity Modulated Radiotherapy treatment
Intensity Modulated Radiotherapy treatment
Eligibility Criteria
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Inclusion Criteria
* Inoperable Stage III disease (T3N1-3, any T4, any N2 -3) confirmed by PET scanning, mediastinoscopy or thoracoscopy
* Patients treated with at least 2 cycles of platinum based induction chemotherapy and able to start radiotherapy within 5 weeks of the last cycle of chemotherapy
* Tumour judged inoperable by a lung MDT
* Age 18+, no upper age limit
* Performance status (PS) - ECOG 0-2. Patients with PS 2 whose general condition is explained by disease can be included at the discretion of the local investigator. Patients with PS 2 as a result of co-morbid conditions will be excluded
* Patient considered suitable for radical RT
* Tumour that can be encompassed within a radical RT treatment volume (MLD expected to be \<20Gy)
Exclusion Criteria
* Patients only suitable for radical RT due to PS and co-morbidities
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
British Lung Foundation
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Belfast Health and Social Care Trust
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Royal Marsden NHS Foundation Trust
OTHER
East and North Hertfordshire NHS Trust
OTHER_GOV
Prof Corinne Faivre-Finn
OTHER
Responsible Party
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Prof Corinne Faivre-Finn
Prof Corinne Faivre-Finn, Consultant Clinical Oncologist
Principal Investigators
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Corinne Faivre-Finn, MD PhD
Role: PRINCIPAL_INVESTIGATOR
The Christie NHS Foundation Trust
Locations
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Belfast Health & Social Care NHS Trust - Northern Ireland Cancer Centre
Belfast, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield, , United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, , United Kingdom
Countries
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References
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Haslett K, Franks K, Hanna GG, Harden S, Hatton M, Harrow S, McDonald F, Ashcroft L, Falk S, Groom N, Harris C, McCloskey P, Whitehurst P, Bayman N, Faivre-Finn C. Protocol for the isotoxic intensity modulated radiotherapy (IMRT) in stage III non-small cell lung cancer (NSCLC): a feasibility study. BMJ Open. 2016 Apr 15;6(4):e010457. doi: 10.1136/bmjopen-2015-010457.
Other Identifiers
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11_DOG07_136
Identifier Type: -
Identifier Source: org_study_id
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