Frailty-adjusted therapy in transplant non-eligible patients with newly diagnosed multiple myeloma
| ISRCTN | ISRCTN17973108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17973108 |
| EudraCT/CTIS number | 2018-003590-10 |
| IRAS number | 234453 |
| ClinicalTrials.gov number | NCT03720041 |
| Secondary identifying numbers | Version 2.0, 10th October 2019, IRAS 234453 |
- Submission date
- 27/11/2020
- Registration date
- 18/01/2021
- Last edited
- 04/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-ixazomib-lenalidomide-and-dexamethasone-for-people-with-myeloma-fitness
Background and study aims
Myeloma is is a type of bone marrow cancer diagnosed in around 5500 patients in the UK each year. The development of treatments has increased life expectancy in all patients, but these have been less effective in older and frailer patients. There is no evidence to suggest their myeloma is more aggressive, so it needs to be asked why this is the case. Research is beginning to look at older myeloma patients who are ineligible for transplants. Myeloma XI, a previous trial where 1840 of these patients were recruited, has shown that treatment outcomes were not necessarily associated with different combinations of treatment. The aim of this study is to compare standard and frailty-adjusted induction treatment with ixazomib, lenalidomide and dexamethasone and maintenance lenalidomide to lenalidomide plus ixazomib.
Who can participate?
Newly diagnosed myeloma patients, above the age of 18, who are not eligible for a stem cell transplant
What does the study involve?
All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomly allocated to either frailty score-adjusted treatment or standard upfront treatment followed by toxicity-dependent dose modifications during treatment. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation. In the second phase of the trial, patients will be tested to assess whether lenalidomide and ixazomib are effective as a maintenance treatment. Patients will either receive lenalidomide and ixazomib, or lenalidomide and placebo (something that has a similar taste and appearance to ixazomib but has no effect on the person) to test this.
What are the possible benefits and risks of participating?
Evidence from previous trials has shown that patients who are older and living with other health issues do not stay on standard treatment for as long as younger, fitter patients. This study will explore whether tailoring the medication will increase the durability of treatment in older patients to ensure a longer benefit and therefore reduce the risk of having to stop treatment early due to side effects. Participants will be helping to answer important questions and it is hoped that this will improve treatment now and for future patients.
At the moment, neither the IRD induction treatment nor maintenance therapy with either lenalidomide alone or in combination with ixazomib is available on the NHS for the treatment of newly diagnosed myeloma, and so this study gives access to these treatments. Previous studies have shown that maintenance therapy with lenalidomide can increase the length of disease remission. The goal of this study is to gain a greater understanding of the various treatment options available for myeloma patients, how they compare to each other and how they are best delivered to patients. This may or may not be a better approach to treating myeloma compared to what doctors do currently.
There are potential risks associated with the study as well as potential side effects from the trial treatments and drugs. A small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment. Some medications, and complementary health supplements such as St John’s Wort, should not be used during this study as they may interact with the study medications.
Patients who take part in this study are potentially at risk of becoming sterile or infertile. This is also the case with other chemotherapy treatments participants would likely receive if they were not on the study. If appropriate, counselling and a referral for fertility assessment and preservation will be available. Some patients with myeloma find that they can continue to work during treatment.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
August 2017 to August 2027
Who is funding the study?
The study is largely funded by Cancer Research UK. Some of the costs of the drugs being used in the study, as well as some additional funding for the running of the study, is being provided by the companies who make two of the drugs being investigated, Takeda (ixazomib) and Celgene (lenalidomide).
Who is the main contact?
Rowena Henderson
ctru_myelomaxiv@leeds.ac.uk
Contact information
Scientific
Leeds Institute of Clinical Trials Research
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
| Phone | +44 (0)113 343 1159 |
|---|---|
| ctru_myelomaxiv@leeds.ac.uk |
Public
Leeds Institute of Clinical Trials Research
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
| Phone | +44 (0)113 34 39368 |
|---|---|
| ctru_myelomaxiv@leeds.ac.uk |
Study information
| Study design | Multicenter interventional placebo-controlled double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A phase III trial to compare standard and frailty-adjusted induction therapy with ixazomib, lenalidomide and dexamethasone (IRD) and maintenance lenalidomide (R) to lenalidomide plus ixazomib (IR) |
| Study acronym | FiTNEss (UK-MRA Myeloma XIV) |
| Study hypothesis | At R1: That there is a difference in the proportion of patients, categorised as “unfit” or “frail” at trial entry, requiring early cessation of treatment (within 60 days of randomisation) between standard up-front (reactive) or frailty score-adjusted (adaptive) dose modifications, with superiority of the frailty score-adjusted (adaptive) dose modifications anticipated. The null hypothesis is that that there is no difference. At R2: That there is a difference in progression-free survival between lenalidomide + placebo (R) and lenalidomide + ixazomib (R + I) maintenance therapy with superiority of R + I maintenance therapy anticipated. The null hypothesis is that there is no difference. |
| Ethics approval(s) | Approved 11/09/2019, North East – Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood & Transplant Centre Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44(0) 207 1048084; nrescommittee.northeast-tyneandwearsouth@nhs.net), REC ref: 19/NE/0215 |
| Condition | Multiple myeloma |
| Intervention | All participants receive 12 cycles of induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose modifications during therapy. Randomisation 1 will be completed using a computer generated minimisation algorithm that incorporates a random element to ensure that all arms are well balanced for specific participant characteristics, details of which will be required at randomisation. Participants randomised to the frailty adjusted arm will undergo assessment for frailty according to the IMWG Frailty Index be categorised as fit, unfit or frail. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation. Randomisation 2 will be completed using a computer generated minimisation algorithm that incorporates a random element to ensure that all arms are well balanced for specific participant characteristics, details of which will be required at randomisation. Ixazomib is an oral hard gelatin capsule that is taken orally. Lenalidomide is a hard capsule that is taken orally. Dexamethasone is a hard capsule that is taken orally. The placebo is an oral hard gelatin capsule that is taken orally. All participants will receive 12 cycles of induction treatment, each treatment cycle is 28 days in length. Participants who are randomised to the standard up-front dosing followed by toxicity dependent dose-modifications (reactive) arm will receive: 4 mg of ixazomib on days 1, 8 and 15 25 mg of lenalidomide on days 1-21 40 mg of dexamethasone in participants ≤75 years or 20 mg dexamethasone in participants >75 years on days 1, 8, 15, 22 Participants randomised to the frailty score-adjusted dosing arm (adaptive) and are categorised as FIT will receive: 4 mg of ixazomib on days 1, 8 and 15 25 mg of lenalidomide on days 1-21 40 mg of dexamethasone on days 1, 8, 15, 22 Participants randomised to the frailty score-adjusted dosing arm (adaptive) and are categorised as UNFIT will receive: 4 mg of ixazomib on days 1, 8 and 15 15 mg of lenalidomide on days 1-21 20 mg of dexamethasone on days 1, 8, 15, 22 Participants randomised to the frailty score-adjusted dosing arm (adaptive) and are categorised as FRAIL will receive: 4 mg of ixazomib on days 1, 8 and 15 10 mg of lenalidomide on days 1-21 10 mg of dexamethasone on days 1, 8, 15, 22 Participants who progress to maintenance and are randomised to receive lenalidomide and placebo will receive: 10 mg of lenalidomide on days 1-21 4 mg of placebo on days 1, 8, 15 Participants who progress to maintenance and are randomised to receive lenalidomide and placebo will receive: 10 mg of lenalidomide on days 1-21 4 mg of ixazomib on days 1, 8, 15 The duration of trial treatment for individual participants will vary, as treatment will continue until disease progression or intolerable toxicity. On average, it is expected that a participant will receive trial treatment for an average of 37 months: they will receive 12 cycles of IRD induction, followed by a median of 25 cycles of maintenance. All cycles last for 28 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Ixazomib, lenalidomide, dexamethasone |
| Primary outcome measure | Randomisation 1 (R1): Early treatment cessation (yes or no). Participants will be defined to have ceased treatment early if they die, progress, or are withdrawn from treatment (by a treating clinician) or withdraw consent for trial treatment, within 60 days of R1. Randomisation 2 (R2): Progression-free survival (PFS-R2): time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free |
| Secondary outcome measures | Measured using eCRFs and patient records unless otherwise indicated: 1. Progression-free survival (PFS-R1): the time from R1 to the time of first documented evidence of disease progression or death from any cause. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma 2. Time to progression: the time from randomisation to the date of first documented evidence of disease progression 3. Time to Progression-free survival two (PFS2): time from randomisation to the time of the second documented disease progression or death from any cause 4. Overall survival (OS): the time from randomisation to the time of death from any cause 5. Survival after progression: time from the date of first documented evidence of disease progression to the date of death from any cause 6. Death within 12 months of R1 (yes or no) 7. Overall response rate (ORR): whether a participant had sCR, CR, VGPR, PR, MR, SD or PD at the end of induction according to the IMWG Uniform Response Criteria for Multiple Myeloma 8. Attainment of ≥VGPR (yes or no) 9. Attainment of Minimal Residual Disease (MRD) negativity (yes or no, according to the IMWG MRD criteria) 10. Duration of response (DoR): time from the first observation of response ≥ PR, following R1, to the time of first documented evidence of disease progression or death confirmed related to progression 11. Time to improved response: time from the date of R2 to the date the response category is first improved based on the Modified International Uniform Response Criteria for Multiple Myeloma 12. Time to next treatment: time from R1 to the start date of the next line of treatment (i.e. treatment following documented evidence of progressive disease) or death from any cause 13. Treatment compliance and total amount of therapy delivered: 13.1. Did the participant receive 12 cycles of induction treatment (yes or no) 13.2. Number of induction and maintenance cycles which the participant received. This may be extended to consider the percentage of protocol dose delivered. For each treatment (ixazomib, lenalidomide, dexamethasone) this will be defined as the total dose received in a cycle compared to the total dose the participant should have received in the cycle without modifications, averaged across all cycles of treatment 14. Toxicity and safety reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments at each centre. The number of SAEs will be reported according to MedDRA System Organ Class. All second primary malignancies will be reported based on information collected on the CRF 15. Quality of Life (QoL) using the patient-reported outcome measures; EORTC-QLQ-C30, EORTC-QLQ-MY20 and EQ-5D (3 Level) at R1, after cycles 2,6 and 12 during induction treatment. They are also collected after cycles 6 and 12 during maintenance treatment 16. Cost-effectiveness: cost per incremental QALY below £20,000 and/or a positive incremental net monetary benefit. For R1, the cost-effectiveness of standard dose IRD vs frailty adjusted dose IRD will be analysed. For R2, the cost-effectiveness of maintenance therapy using R vs R+I will be analysed Added 07/07/2022: 17. Event-free survival (EFS) is measured from randomisation to the first instance of one of the following events; death, progression, discontinuation of the randomised treatment, a grade 4 haematological toxicity or a non-haematological toxicity ≥grade 3 |
| Overall study start date | 15/08/2017 |
| Overall study end date | 31/08/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 740 |
| Total final enrolment | 733 |
| Participant inclusion criteria | Inclusion criteria for Randomisation 1 (R1): 1. Newly diagnosed as having MM according to the updated IMWG diagnostic criteria 2014 requiring treatment 2. Not eligible for stem cell transplant 3. Aged at least 18 years 4. Meet all of the following blood criteria within 14 days before R1: 4.1. Haematological: 4.1.1. Absolute neutrophil count (ANC) ≥ 1 x 10^9/l. Unless the participant has a known/suspected diagnosis of familial or racial neutropenia in which case an ANC ≥0.75 x 10^9/l is allowed. The use of growth factor support is permitted 4.1.2. Platelet count ≥50 x 10^9/l, or, in the case of heavy bone marrow infiltration (≥50%) which in the opinion of the investigator is the cause of the thrombocytopenia and provided appropriate supportive measures and patient monitoring are in place, platelet count ≥30 x 10^9/l is permitted. Please note: Platelet transfusions are not allowed ≤3 days prior to randomisation in order to meet these values 4.1.3. Haemoglobin ≥80 g/l. The use of red blood cell transfusions is permitted 4.2. Biochemical: 4.2.1. Total bilirubin ≤ 3 x upper limit of normal (ULN) 4.2.2. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3 x ULN 5. Meet the pregnancy prevention requirements 6. Able to provide written informed consent Inclusion criteria for Randomisation 2 (R2): 1. Randomised into the FiTNEss (Myeloma XIV) trial and received induction chemotherapy with ixazomib and lenalidomide continued for 12 cycles 2. Achieved at least MR at the end of IRD induction according to the IMWG Uniform Response Criteria for Multiple Myeloma, with no evidence of progression prior to R2 3. Meet all of the following blood criteria within 14 days before R2: 3.1. Haematological: 3.1.1. Absolute neutrophil count (ANC) ≥1 x 10^9/l. Unless the participant has a known/suspected diagnosis of familial or racial neutropenia in which case an ANC ≥0.75 x 10^9/l is allowed. The use of growth factor support is permitted 3.1.2. Platelet count ≥50 x 10^9/l. Please note: Platelet transfusions are not allowed ≤3 days prior to randomisation in order to meet these values 3.1.3. Haemoglobin ≥80 g/l. The use of red blood cell transfusions is permitted 3.2. Biochemical: 3.2.1. Total bilirubin ≤3 x upper limit of normal (ULN) 3.2.2. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3 x ULN |
| Participant exclusion criteria | Exclusion criteria at R1: 1. Smouldering MM, MGUS, solitary plasmacytoma of bone, or extramedullary plasmacytoma (without evidence of MM) 2. Received previous treatment for MM, with the exception of local radiotherapy to relieve bone pain or spinal cord compression, prior bisphosphonate treatment, or corticosteroids as long as the total dose does not exceed the equivalent of 160 mg dexamethasone 3. Known resistance, intolerance or sensitivity to any component of the planned therapies 4. Prior or concurrent invasive malignancies except the following: 4.1. Adequately treated basal cell or squamous cell skin cancer 4.2. Incidental finding of low grade (Gleason 3+3 or less) prostate cancer requiring no intervention 4.3. Adequately treated carcinoma in situ of the breast or cervix no longer requiring medical or surgical intervention 4.4. Any cancer from which the subject has been disease-free for at least 3 years 5. Pregnant, lactating or breastfeeding female participants 6. Major surgery within 14 days before randomisation. This would include surgical intervention for relief of cord compression but does not include vertebroplasty or kyphoplasty 7. Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St John’s wort 8. Any concomitant drug therapy which, in the opinion of the investigator, may lead to an unacceptable interaction with any of the agents ixazomib, lenalidomide, dexamethasone, and that cannot be safely stopped prior to trial entry. Full details of interactions can be found in the SPCs 9. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing 10. ≥ Grade 2 peripheral neuropathy 11. Known HIV positive 12. Participant has current or prior hepatitis B surface antigen-positive or hepatitis C antibody positive. Participants must have screening conducted within 14 days before R1 13. Active systemic infection 14. Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant’s participation in this study 15. Receipt of live vaccination within 30 days prior to R1 Exclusion criteria for R2: 1. Received any anti-myeloma therapy other than their randomised trial treatment, with the exception of local radiotherapy to relieve bone pain (in the absence of disease progression), or bisphosphonate treatment 2. SD or disease progression according to the IMWG Uniform Response Criteria for Multiple Myeloma (see Appendix 2) 3. Known resistance, intolerance or sensitivity to ixazomib or lenalidomide that required cessation of either agent during induction 4. Developed any malignancy since R1 except the following: 4.1. Adequately treated basal cell or squamous cell skin cancer 4.2. Incidental finding of low grade (Gleason 3+3 or less) prostate cancer requiring no intervention 4.3. Adequately treated carcinoma in situ of the breast or cervix no longer requiring medical or surgical intervention 5. Pregnant, lactating or breastfeeding female participants 6. Major surgery within 14 days before randomisation. This does not include vertebroplasty or kyphoplasty 7. Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St John’s wort 8. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing 9. ≥ Grade 2 peripheral neuropathy, or grade 1 with pain 10. Known HIV positive 11. Current or known hepatitis B surface antigen positive or hepatitis C antibody positive 12. Active systemic infection 13. Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant’s continued participation in this study 14. Receipt of live vaccination within 30 days prior to R1 or receipt of live vaccination at any point during the trial prior to R2 |
| Recruitment start date | 04/08/2020 |
| Recruitment end date | 04/02/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Exeter
EX2 5DW
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Swansea
SA2 8QA
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Lindley
Huddersfield
HD3 3EA
United Kingdom
HX3 0PW
United Kingdom
Sunderland
SR4 7TP
United Kingdom
South Shields
NE34 0PL
United Kingdom
Canterbury
CT1 3NG
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Margate
CT9 4AN
United Kingdom
Colchester
CO4 5JL
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Kettering
NN16 8UZ
United Kingdom
London
SE5 9RS
United Kingdom
Orpington
BR6 8ND
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Davyhulme
Manchester
M41 5SL
United Kingdom
Manchester
M13 9WL
United Kingdom
Wythensahwe
Manchester
M23 9LT
United Kingdom
Newcastle Upon Tyne
NE7 7DN
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
DD1 9SY
United Kingdom
Norwich
NR4 7UY
United Kingdom
BS10 5NB
United Kingdom
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom
PE29 6NT
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Reading
RG1 5AN
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
DL6 1JG
United Kingdom
London
SW17 0QT
United Kingdom
St. Helens
WA9 3DA
United Kingdom
Prescot
L35 5DR
United Kingdom
Torquay
TQ2 7AA
United Kingdom
King Edward Yard
Marlborough Hill
Bristol
BS2 8HW
United Kingdom
Derbym
DE22 3NE
United Kingdom
London
NW1 2BU
United Kingdom
Wigan
WN1 2NN
United Kingdom
Leicester
LE2 7LG
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Worthing
BN11 2DH
United Kingdom
Chichester
PO19 6SE
United Kingdom
Road Hereford
HR1 2BN
United Kingdom
Sponsor information
University/education
UoL/LTHT Joint Sponsor QA Office (CTIMPs)
St James' University Hospital
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)1133432813 |
|---|---|
| ctru_myelomaxiv@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Takeda Pharmaceuticals International AG, Takeda Pharmaceuticals International GmbH
- Location
- Switzerland
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Celgene Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/08/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 04/07/2022: Data from this study will be published once trial endpoints have been reached and after the overall trial end date. Publication will be via peer-reviewed journals as well as via presentations at conferences. The results will also be available on UK cancer websites such as Myeloma UK and Cancer Research UK. Previous publication and dissemination plan: The protocol is not currently available. A protocol publication, based on the RADAR protocol will be available at a later date. Data from this study will be published once trial endpoints have been reached and after the overall trial end date. Publication will be via peer-reviewed journals as well as via presentations at conferences. The results will also be available on UK cancer websites such as Myeloma UK and Cancer Research UK. |
| IPD sharing plan | De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as CTRU retains the data. CTRU makes data available by a 'controlled access' approach. Data will only be released for legitimate secondary research purposes, where the Chief Investigator, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (in terms of scientific rigour and information governance and security), and that there are resources available to satisfy the request. Data will only be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the released data at the end of the planned project. The CTRU encourages a collaborative approach to data sharing and believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, copies of key trial documents and any other information required to understand and reuse the released datasets. The conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree on suitable requirements for release. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/06/2022 | 08/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/03/2024: The following changes were made to the trial record:
1. The overall end date was changed from 04/08/2026 to 31/08/2027.
2. The study participating centre Harrogate District Hospital was removed
3. The intention to publish date was changed from 04/08/2027 to 31/08/2028.
4. The plain English summary was updated to reflect these changes.
5. Total final enrolment added.
15/02/2023: The recruitment end date was changed from 04/02/2023 to 04/02/2024.
07/07/2022: The following changes were made to the trial record:
1. The overall trial start date was changed from 07/09/2020 to 15/08/2017.
2. The recruitment start date was changed from 07/09/2020 to 04/08/2020.
3. The recruitment end date was changed from 07/03/2023 to 04/02/2023.
4. The overall trial end date was changed from 07/09/2026 to 04/08/2026.
5. The secondary outcome measures were updated.
6. Intention to publish date added.
04/07/2022: Publication and dissemination plan and IPD sharing statement updated.
08/06/2022: Publication reference added.
13/04/2021: Cancer Research UK lay summary link added to plain English summary field.
03/12/2020: Trial’s existence confirmed by NHS HRA.
