Topic: Cancer
Conditions
Interventions
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
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The identification and validation of potential biomarkers in the form of specific differences in metastatis | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Contacts
Public ContactMohana Suppiah
Outcome results
None listed