MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Capecitabine
Pharmaceutical Form: Tablet
INN or Proposed INN: Capecitabine
Other descriptive name: CAPECITABINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentratio
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Metastatic colorectal cancer o Biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis) o If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the colon or rectum (scanning or endoscopy) o Non-resectable metastatic spread • Exposed to or intolerance or contraindications to standard systemic therapy, defined as o oxaliplatin o irinotecan o 5-fluorouracil (or similar such as capecitabine, S1) o VEGF inhibitor bevacizumab o EGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt) • Progressive disease defined as progression according to RECIST 1.1 • ECOG performance status 0-2 • Age at least 18 years • Adequate bone marrow, liver and renal function allowing systemic chemotherapy o Absolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/l. o Bilirubin = 1.5 x upper normal value and alanine aminotransferase = 3 x upper normal value o Calculated or measured renal glomerular filtration rate at least 30 mL/min • Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable • Written and orally informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol • Other active malignant disease requiring therapy • Other systemic anti-cancer therapy (palliative radiotherapy is allowed). • Pregnant (positive pregnancy test) or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the present study is to investigate the benefit to patients with metastatic colorectal cancer of post standard anti-cancer therapy based on pretreatment in-vitro testing of drug sensitivity to patient-derived tumorspheres.;Secondary Objective: Not applicable;Primary end point(s): The fraction of patients alive and without progression eight weeks after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival (PFS) and overall survival (OS) • Response rate (RR) • Quality of life (QoL) • Dynamics of circulation tumor DNA during treatment • Correlation studies between specific molecular tumor alterations and clinical outcome | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Vejle Hospital
Outcome results
None listed