Metastatic Colorectal Cancer MedDRA version: 17.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Teysuno
Pharmaceutical Form: Capsule
Trade Name: Xeloda
Pharmaceutical Form: Film-coated tablet
Trade Name: Xeloda
Pharmaceutical Form: Film-coated tablet
Trade Name: Teysuno
Pharmaceut
Sponsors
Dutch Colorectal Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histological proof of colorectal cancer. • Distant metastases (patients with only local recurrence are not eligible) • Unidimensionally measurable disease (=1 cm on spiral CT scan or =2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation. • In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field. • Age = 18 years • Planned first line treatment with capecitabine monotherapy with or without bevacizumab. • WHO performance status 0-2 (Karnofsky PS =70%); • Laboratory values obtained within 2 weeks prior to randomisation: • adequate bone marrow function (Hb = 6.0 mmol/L, absolute neutrophil count =1.5 x 109/L, platelets = 100 x 109/L), renal function (serum creatinine = 1.5x ULN and creatinine clearance, Cockroft formula, =30 ml/min), liver function (serum bilirubin = 2 x ULN, serum transaminases = 3 x ULN without presence of liver metastases or = 5x ULN with presence of liver metastases). • Life expectancy > 12 weeks. • Negative pregnancy test in women with childbearing potential. • Expected adequacy of follow-up. • Institutional Review Board approval. • Written 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Prior adjuvant treatment for stage II/III colorectal cancer completed within 6 months prior to randomisation. • Any prior adjuvant treatment after resection of distant metastases. • Any prior systemic treatment for advanced disease. • History or clinical signs/symptoms of CNS metastases. • History of a second malignancy 150/100 mmHg. • Use of = 3 antihypertensive drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. ;Secondary Objective: • Incidence of grade 3 hand-foot syndrome • Incidence of other toxicities • Progression-free survival • Response rate • Overall survival ;Primary end point(s): A decreased incidence of HFS from 30 % for capecitabine to 10 % for S-1. ;Timepoint(s) of evaluation of this end point: 6 months after the last patient has been included. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival calculated from date of randomisation to death or to last known to be alive. Response rate after the 6th cycle of treatment. Adverse events according th NCI CTC criteria Progression free survival calculated from randomisation to date of first progression or death whichever comes first;Timepoint(s) of evaluation of this end point: 6 months after the last patient has been included. | — |
Countries
Netherlands
Contacts
Public ContactIKNL Clinical Research Centre
Comprehensive Cancer Centre The Netherlands
Outcome results
None listed