Lung CancerACCOLADENCT03645317
Avoiding Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy
A study testing Blood tests & cardiac imaging in people with Lung Cancer, run by Prof Corinne Faivre-Finn at 2 sites in United Kingdom.
Trial summary
Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Blood tests & cardiac imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Jun 2019to 1 Jul 2022
- 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
- Histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) suitable for curative-intent radiotherapy
- Patients suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- Life expectancy > 4 months
- Age ≥ 18 years
- Patient has read and understood the participant information sheet and given informed consent
Who cannot join
- No histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) and not suitable for curative-intent radiotherapy
- Patients not suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- Life expectancy < 4 months
- Age < 18 years
- Patient has not read and understood the participant information sheet and has not given informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Elizabeth Craven, MSc, 0161 446 3045, Elizabeth.Craven@machester.ac.uk
Kevin Franks
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Kate Wicks, PhD, Kate.Wicks@manchester.ac.uk
Corinne Faivre-Finn
About this study
Official title: A Study Investigating How to Avoid Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy to Improve Survival, Funded by Yorkshire Cancer Research
Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. The precise mechanism of damage and which areas of the heart are more sensitive to radiation is not currently known. This project uses the analysis of large amounts of existing radiotherapy treatment data to determine this. Establishing detailed radiotherapy dose limits for the heart and the heart's sub-structures will lead to the delivery of heart-sparing radiotherapy, where possible, in lung cancer patients treated in Yorkshire and Greater Manchester. The investigators estimate that this should lead to an improvement in one-year survival of approximately 10%.
- Conditions
- Lung Cancer
- Being tested
- Blood tests & cardiac imaging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood tests & cardiac imagingDiagnostic test
Blood tests (full blood count, lipids, cholesterol, high sensitivity Troponin levels, C-reactive protein (CRP) and brain natriuretic peptide) Cardiac imaging - cardiac CT, cardiac ultrasound, 12-lead ECG
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Blood samples (FBC, lipids, cholesterol, troponin, CRP, BNP) Cardiac imaging (cardiac CT, cardiac ultrasound, 12-lead ECG) Receives: Diagnostic Test: Blood tests & cardiac imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of radiation dose to the heart assessed using blood test (full blood count)
The effect of radiation dose to the heart assessed using full blood count measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels)
The effect of radiation dose to the heart assessed using lipid \& cholesterol (LDL \& HDL) measurements at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using blood test (troponin)
The effect of radiation dose to the heart assessed using troponin measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using blood test (C-reactive protein)
The effect of radiation dose to the heart assessed using C-reactive protein measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide)
The effect of radiation dose to the heart assessed using brain natriuretic peptide measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound)
The effect of radiation dose to the heart assessed using cardiac ultrasound scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac ultrasound measured during the study: parasternal long axis, parasternal short axis, apical 2/4/5 chambers, apical long axis, subcostal and parasternal notch.
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT)
The effect of radiation dose to the heart assessed using cardiac CT scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac CT scan measured during the study: coronary calcium score (Agaston/Volume) - CAC-RDS 0, CAC-RDS 1, CAC-RDS 2, CAC-RDS 3, CAC-RADS classification.
Measured: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG)
The effect of radiation dose to the heart assessed using 12-lead ECG at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the ECG measured during the study: heart rate, rhythm, P wave, QRS complex, QT interval, ST segment \& PR interval.
Measured: 4 months (duration of each participant on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start12 Jun 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Corinne Faivre-Finn
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, University of Manchester, University of Leeds, Manchester University NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Prof Corinne Faivre-Finn, The Christie NHS Foundation Trust
- Investigators
- Corinne Faivre-Finn, PhD, Principal investigator, The Christie NHS Foundation Trust / Univerrsity of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645317
- Sponsor's protocol ID
- M401
- Acronym
- ACCOLADE
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share data
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating How to Avoid Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy to Improve Survival, Funded by Yorkshire Cancer Research
- ClinicalTrials.gov ID
- NCT03645317
- Acronym / sponsor ID
- ACCOLADE / M401
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prof Corinne Faivre-FinnUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, University of Manchester, University of Leeds, Manchester University NHS Foundation Trust
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 24 Aug 2018 (actual)
- 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.
Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. The precise mechanism of damage and which areas of the heart are more sensitive to radiation is not currently known. This project uses the analysis of large amounts of existing radiotherapy treatment data to determine this. Establishing detailed radiotherapy dose limits for the heart and the heart's sub-structures will lead to the delivery of heart-sparing radiotherapy, where possible, in lung cancer patients treated in Yorkshire and Greater Manchester. The investigators estimate that this should lead to an improvement in one-year survival of approximately 10%.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Diagnostic Test: Blood tests & cardiac imagingBlood samples (FBC, lipids, cholesterol, troponin, CRP, BNP) Cardiac imaging (cardiac CT, cardiac ultrasound, 12-lead ECG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) suitable for curative-intent radiotherapy
- Patients suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- Life expectancy > 4 months
- Age ≥ 18 years
- Patient has read and understood the participant information sheet and given informed consent
Key exclusion criteria (5 listed)
- No histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) and not suitable for curative-intent radiotherapy
- Patients not suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- Life expectancy < 4 months
- Age < 18 years
- Patient has not read and understood the participant information sheet and has not given informed consent
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 |
|---|---|---|
| Blood tests & cardiac imagingBlood tests (full blood count, lipids, cholesterol, high sensitivity Troponin levels, C-reactive protein (CRP) and brain natriuretic peptide) Cardiac imaging - cardiac CT, cardiac ultrasound, 12-lead ECG | Diagnostic test | Single arm |
Primary outcome
The effect of radiation dose to the heart assessed using blood test (full blood count)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using full blood count measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using lipid \& cholesterol (LDL \& HDL) measurements at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (troponin)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using troponin measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (C-reactive protein)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using C-reactive protein measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using brain natriuretic peptide measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac ultrasound scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac ultrasound measured during the study: parasternal long axis, parasternal short axis, apical 2/4/5 chambers, apical long axis, subcostal and parasternal notch.
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac CT scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac CT scan measured during the study: coronary calcium score (Agaston/Volume) - CAC-RDS 0, CAC-RDS 1, CAC-RDS 2, CAC-RDS 3, CAC-RADS classification.
The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG)
Time frame: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using 12-lead ECG at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the ECG measured during the study: heart rate, rhythm, P wave, QRS complex, QT interval, ST segment \& PR interval.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No. No plans to share data
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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, PhD principal investigator
The Christie NHS Foundation Trust / Univerrsity of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood tests & cardiac imaging in people with Lung Cancer, run by Prof Corinne Faivre-Finn at 2 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corinne Faivre-Finn, PhD (0044 (0)161 446 8200 ext. 8200, corinne.finn@christie.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of radiation dose to the heart assessed using blood test (full blood count) (time frame: 4 months (duration of each participant on study)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2021.