Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 7
- Primary Endpoint
- The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT.
Study Overview
Brief Summary
This study is for patients having a course of chest radiotherapy treatment after receiving chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.
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.
Detailed Description
Background:
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed NSCLC
- •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-
- •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 suitable for standard concurrent CTRT
- •Patients only suitable for radical RT due to PS and co-morbidities
Arms & Interventions
Thoracic radiotherapy
Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks)
Intervention: Intensity Modulated Radiotherapy treatment (Radiation)
Outcomes
Primary Outcomes
The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT.
Time Frame: Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT
Radiotherapy treatment plans \& OAR tolerance doses will be analysed to assess the feasibility of delivering the proposed treatment.
Secondary Outcomes
- The number of participants from the study population who are suitable to receive isotoxic IMRT treatment.(12 months)
- The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities(12 months)
- The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity(12 months)
- Number of participants whose disease is controlled locally & overall survival rates(Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years)
Investigators
Prof Corinne Faivre-Finn
Prof Corinne Faivre-Finn, Consultant Clinical Oncologist
The Christie NHS Foundation Trust