Metastatic, non-resectable and chemo-refractory colorectal cancer MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Lonsurf
Product Name: Lonsurf
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Tipiracil, Trifluridin
CAS Number: 733030-01-8
Other descriptive name: TIPIRACIL HYDROCHLORIDE MIXTURE
Sponsors
Odense Universitetshospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years. • Histologically verified colorectal adenocarcinoma. • Non-resectable mCRC. • Measurable or non-measurable disease. • Performance status (WHO) of 0-1 and a life expectancy of at least 3 months. • Failure of previous (or intolerance to) fluoropyrimidines, irinotecan, oxaliplatin, cetuximab or panitumumab (only for RAS wild type); prior bevacizumab, aflibercept or regorafenib allowed but not mandatory. • Adequate haematological function defined as neutrophils 1.5 x 109/l and platelets = 100 x 109/l. • Adequate organ function (bilirubin = 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min. • Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomisation. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) during the study and for 6 months after the discontinuation of study medication. • Has provided written informed consent prior to performance of any study procedure. • Written informed consent must be obtained according to the local Ethics Committee requirements. 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 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: • Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and any other cancer in complete remission for at least 2 years. • Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives. • Known allergy or intolerance to any of the drugs used (Lonsurf, bevacizumab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: • Progression-free survival (PFS) ;Secondary Objective: Secondary objectives: • Overall survival (OS) • Response rate (RR) according to RECIST criteria version 1.1 • Toxicity • Correlation between tumour markers and outcome ;Primary end point(s): Primary end-point: • Progression-free survival (PFS) ;Timepoint(s) of evaluation of this end point: The trial is expected to start right after the Danish Authorities approval of the protocol has been granted. Target recruitment period is estimated to be 18 months and follow-up period/end date is estimated to be 3 months after inclusion of last patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points: *Overall survival (OS) *Toxicity-profile *Tumour markers (blood tests) ;Timepoint(s) of evaluation of this end point: The trial is expected to start right after the Danish Authorities approval of the protocol has been granted. Target recruitment period is estimated to be 18 months and follow-up period/end date is estimated to be 3 months after inclusion of last patient. | — |
Countries
Denmark
Contacts
Public ContactPer Pfeiffer
Odense Universitetshospital
Outcome results
None listed