Health Condition 1: N399- Disorder of urinary system, unspecified
Conditions
Interventions
Intervention1: Artesunate: It is a randomised, double blind, placebo controlled, multi-centre trial. We aim to recruit 623 patients presenting with colorectal cancer over a 2 year period. Patients who
Sponsors
BDUK Building Digital UK
Eligibility
Inclusion criteria
Inclusion criteria: biopsy WHO performance status Patient willing to participate resectable disease following neoadjuvant chemotherapy adequate blood count adequate hepatobiliary function adequate renal function
Exclusion criteria
Exclusion criteria: artesunate hypersensitivity history of hearing and balance problem lactation or pregnancy male or fenale unwilling to effective contraception menthod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether peri-adjuvant oral artesunate improves recurrence free (disease free) survival in patients with colorectal cancer compared to surgery +/- Neoadjuvant chemo-radiotherapy alone.Timepoint: 6 MONTHS FOR 3 YEARS | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of peri-neoadjuvant artesunate on disease free survival at 3 years post randomisation To assess the impact of peri-adjuvant oral artesunate on overall survival at 3 and 5 years. To assess the prognostic and predictive value of p53, MMR, MSI and Kras mutation with and without artesunate treatment To conduct cytokine assays (TNFalfa, IL6, IL1, VEGF) in patients with colorectal cancer (with and without artesunate) Timepoint: Recurrence free survival at 5 year | — |
Countries
India
Contacts
Public ContactAvanish Saklani
Tata Memorial Hospital
Outcome results
None listed