Non Small Cell Lung Cancer Clinical Trial
— Isotoxic-IMRTOfficial title:
Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
NCT number | NCT01836692 |
Other study ID # | 11_DOG07_136 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | June 2018 |
Verified date | October 2018 |
Source | The Christie NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | June 2018 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 0-2. 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 suitable for standard concurrent CTRT - Patients only suitable for radical RT due to PS and co-morbidities |
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Prof Corinne Faivre-Finn | Belfast Health and Social Care Trust, British Lung Foundation, Cambridge University Hospitals NHS Foundation Trust, Cancer Research UK, East and North Hertfordshire NHS Trust, Royal Marsden NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT. | Radiotherapy treatment plans & OAR tolerance doses will be analysed to assess the feasibility of delivering the proposed treatment. | Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT | |
Secondary | The number of participants from the study population who are suitable to receive isotoxic IMRT treatment. | Stage 1 - if 13/19 patients can be planned to a dose of >60 Gy EQD2 the study will proceed to stage 2 and recruit a further 16 patients. Assessed via RT planning data. | 12 months | |
Secondary | The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity | Stage 1 - if <3/19 participants experience grade 3+ acute pulmonary toxicity the study will proceed to stage 2 and recruit a further 16 patients. Assessed via toxicity data. | 12 months | |
Secondary | The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities | To assess via toxicity data, the number of patients who experience grade 3+ non haematological toxicities and other late toxicities | 12 months | |
Secondary | Number of participants whose disease is controlled locally & overall survival rates | After completion of radiotherapy treatment regular follow up will continue and data on long term toxicity, local control and survival will be collected. | Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years |
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