The MAGENTA trial: The molecular biology of metastatic cancer

ISRCTN	ISRCTN23406143
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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-find-why-cancer-treatment-stops-working-magenta

Contact information

Miss Mohana Suppiah
Public

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Study design	Non-randomised clinical laboratory study
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
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

Charing Cross Hospital

Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor information

Imperial College London
University/education

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom

"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Research organisation

Experimental Cancer Medicine Centre Network

No information available

Results and Publications

Intention to publish date
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?
HRA research summary			28/06/2023	No	No

Editorial Notes

14/09/2016: Cancer Help UK lay summary link added.