Non Small Cell Lung CancerIsotoxic-IMRTNCT01836692
Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
A study testing Intensity Modulated Radiotherapy treatment in people with Non Small Cell Lung Cancer, run by Prof Corinne Faivre-Finn at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Intensity Modulated Radiotherapy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Apr 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients suitable for standard concurrent CTRT
- Patients only suitable for radical RT due to PS and co-morbidities
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Belfast Health & Social Care NHS Trust - Northern Ireland Cancer Centre
Belfast
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge
Beatson West of Scotland Cancer Centre
Glasgow
Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds
The Christie NHS Foundation Trust
Manchester
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield
The Royal Marsden NHS Foundation Trust
Surrey
About this study
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:
Read more
- 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.
Read the 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:
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
- Non Small Cell Lung Cancer
- Being tested
- Intensity Modulated Radiotherapy treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Radiotherapy treatmentRadiation
Intensity Modulated Radiotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Thoracic radiotherapy | Experimental | Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks) Receives: Radiation: Intensity Modulated Radiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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.
Measured: Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Corinne Faivre-Finn
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, British Lung Foundation, Sheffield Teaching Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, The Leeds Teaching Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Royal Marsden NHS Foundation Trust, East and North Hertfordshire NHS Trust
- Responsible party
- Sponsor-investigator, Prof Corinne Faivre-Finn, The Christie NHS Foundation Trust
- Investigators
- Corinne Faivre-Finn, MD PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836692
- Sponsor's protocol ID
- 11_DOG07_136
- Acronym
- Isotoxic-IMRT
- Status last verified
- Oct 2018
- First submitted
- 12 Apr 2013
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27084277
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
- ClinicalTrials.gov ID
- NCT01836692
- Acronym / sponsor ID
- Isotoxic-IMRT / 11_DOG07_136
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Prof Corinne Faivre-FinnUniversity, hospital or other
- Collaborators
- Cancer Research UK, British Lung Foundation, Sheffield Teaching Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, The Leeds Teaching Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Royal Marsden NHS Foundation Trust, East and North Hertfordshire NHS Trust
- Study start
- Apr 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic radiotherapy | Experimental | Radiation: Intensity Modulated Radiotherapy treatmentIntensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Patients suitable for standard concurrent CTRT
- Patients only suitable for radical RT due to PS and co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity Modulated Radiotherapy treatmentIntensity Modulated Radiotherapy treatment | Radiation | Thoracic radiotherapy |
Primary outcome
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.
4 secondary outcomes
The number of participants from the study population who are suitable to receive isotoxic IMRT treatment.
Time frame: 12 months
The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity
Time frame: 12 months
The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities
Time frame: 12 months
Number of participants whose disease is controlled locally & overall survival rates
Time frame: Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Derived from this study: PubMed 27084277Haslett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Faivre-Finn, MD PhD principal investigator
The Christie NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity Modulated Radiotherapy treatment in people with Non Small Cell Lung Cancer, run by Prof Corinne Faivre-Finn at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.