In-vitro testing anti-cancer therapy sensitivity on tumorspheres
Research type
Research Study
Full title
Prospective, randomised, multi-centre, open label trial of the IndiTreat assay in metastatic colorectal cancer patients.
IRAS ID
255731
Contact name
Helen Bermingham
Contact email
Sponsor organisation
2Curex
Clinicaltrials.gov Identifier
TBC, NCT Number
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Colorectal cancer is common. Patients with local or metastatic spread are given chemotherapy as standard care. If the patient’s disease progresses despite chemotherapy, then standard of care becomes best supportive management or enrolment in clinical trials. We want to explore if previously used antineoplastic drugs and drugs approved for other cancer types may benefit specific colorectal cancer patients.
Individual patients who are chemonaïve with metastatic colorectal cancer who are unsuitable for primary surgery will undergo a biopsy. A tumorsphere will be grown, to select drugs that may have clinical response. The patient will undergo first line chemotherapy and a CT scan will be performed after 8 weeks (42-63 days) to assess progression of tumour, if they have progressive disease(PD)the patient will be randomised to either standard secondline treatment or IndiTreat assay based secondline treatment. All patients will have a CT/MRI every 12 weeks for up to 6 months or until PD or until objective response allowing for surgery. If there is PD on 2ndline therapy, further treatment options include best supportive care or doctor's choice who may choose to look at the patient's IndiTreat test results and use 3rdline treatment.
Eligible patients will have metastatic colorectal cancer not suitable for primary resection, are chemonaïve, eligible for first line chemotherapy, have a ECOG performance status 0-2, be over 18 years old and able to consent. The patients would have adequate bone marrow, liver and renal function and anti-contraception for fertile women and for male patients with a fertile partner. Patients would have written and orally informed consent.
Patients will be recruited from the University Hospitals Birmingham. The tumorspheres will be grown and tested against chemotherapy agents at IRB West Laboratories.
We aim to initially recruit 24 patients. If the stopping criterion is not met, then a further 21 patients will be recruited, totalling 45.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0318
Date of REC Opinion
5 May 2021
REC opinion
Further Information Favourable Opinion