The MAGENTA trial: The molecular biology of metastatic cancer
ISRCTN | ISRCTN23406143 |
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DOI | https://doi.org/10.1186/ISRCTN23406143 |
Secondary identifying numbers | 17675 |
- Submission date
- 23/12/2015
- Registration date
- 23/12/2015
- Last edited
- 14/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Miss Mohana Suppiah
Public
Public
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
Study design | Non-randomised clinical laboratory study |
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Primary study design | Observational |
Secondary study design | |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | MAGENTA: Metabonomic-genomic signature correlates of clinical resistance in metastatic cancer treated with anti-EGFR therapy |
Study acronym | MAGENTA |
Study objectives | The aim of this study is to investigate the clinical resistance in metastatic cancer treated with anti-EGFR therapy. |
Ethics approval(s) | London - Queen Square Research Ethics Committee, 02/12/2014, ref: 14/LO/1650 |
Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Colorectal Cancer, Head and Neck Cancer, Lung Cancer; Disease: Colon, Head and Neck, Lung (small cell), Lung (non-small cell), Skin |
Intervention | Patients presenting to the Cancer Centre will receive an information sheet broadly describing research into the molecular biology of metastatic cancer. It will be made clear to patients that clinical information will be coded and linked to the molecular information. Patients with mCRC undergoing treatment with EGFR inhibitors will be the test sample population with an initial aim of 30-50 patients. There will also be a control group of non-EGFR treated patients (RAS- mutant or otherwise) of a minimum of 20 patients. Archival tumour tissue will be collected at baseline with an optional tissue biopsy at disease progression. 2-3 weekly collections of blood and urine will take place. A second control group will consist of 10 patients with any metastatic cancer receiving EGFR inhibitor therapy. |
Intervention type | Other |
Primary outcome measure | The identification and validation of potential biomarkers in the form of specific differences in metastatis |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 02/12/2014 |
Completion date | 06/03/2017 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 70; UK Sample Size: 70 |
Key inclusion criteria | 1. Histologically or cytologically confirmed colorectal cancer; or 2. Histologically or cytological confirmed lung, squamous cell, or head and neck cancers (only 10 patients required) 3. To commence EGFR inhibitor monotherapy or in combination with cytotoxic chemotherapy for the test populationb or to commence any other cytotoxic chemotherapy with or without an angiogenesis inhibitor for the control population 5. Confirmation of tumour KRAS / NRAS status as KRAS / NRAS WT in the test population, with mutation assessments in BRAF, NRAS, PIK3CA exon20 , PTEN if assessable, by means of mutation or relevant analysis performed on representative samples of diagnostic tumour tissue (the same profile will be done in controls with no prerequisite mutation specified entry criteria) 6. Ability to provide informed consent 7. 18 years of age or older 8. ECOG performance status of = 2 9. Life expectancy of at least 12 weeks 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures |
Key exclusion criteria | 1. Brain metastases that are either untreated, symptomatic, or which have not been stable for at least one month after treatment 2. Severe restrictive lung disease or radiological pulmonary findings of “interstitial lung disease” on the CT scan image available prior to commencement of the treatment which, in the opinion of the investigator, represents significant pathology 3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule, including alcohol dependence or drug abuse 4. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule, including alcohol dependence or drug abuse 5. Known human immunodeficiency virus (HIV) infection 6. Presence of grade =2 peripheral neuropathy. 7. Severe or uncontrolled cardiovascular disease (e.g. acute coronary syndromes, cardiac failure NYHA III or IV, clinically relevant myopathy, history of myocardial infarction within the last 12 months, significant arrhythmias) 8. Any co-morbididty that is likely to lead with interference with study treatment |
Date of first enrolment | 02/12/2014 |
Date of final enrolment | 06/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
London
W12 0HS
United Kingdom
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
London
W6 8RF
United Kingdom
Sponsor information
Imperial College London
University/education
University/education
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
https://ror.org/041kmwe10 |
Funders
Funder type
Research organisation
Experimental Cancer Medicine Centre Network
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/09/2016: Cancer Help UK lay summary link added.