S-1 Versus Capecitabine in the First Line Treatment of MCC Patients. (SALTO)
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|ClinicalTrials.gov Identifier: NCT01918852|
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastases||Drug: Capecitabine Drug: Teysuno Drug: Bevacizumab||Phase 3|
Capecitabine, an oral fluoropyrimidine, has shown a comparable efficacy but a better tolerability compared to bolus 5-FU/LV. However, capecitabine has a higher incidence of hand-foot syndrome (HFS). HFS is characterized by erythema, dysesthesia and/or paresthesia of the palms of the hands or soles of feet. In advanced stage, desquamation, ulceration and blistering can occur. Although HFS is not life threatening, it can cause significant discomfort and impairment of function, especially in elderly patients. This adverse event is becoming particularly relevant since many patients may require the administration of capecitabine over prolonged periods of time.
S-1 (Teysuno®) is an oral fluoropyrimidine that has shown comparable efficacy to 5FU and capecitabine in gastrointestinal cancers but is associated with a much lower incidence of HFS. Studies on S-1 have mainly been performed in Asian patients,which population has known differences in tumour biology and toxicity compared to Western population. S-1 has shown comparable efficacy to other fluoropyrimidines as monotherapy or in combination chemotherapy schedules in several gastrointestinal tumors. However, given the lack of data from prospective studies on S-1 as monochemotherapy in metastatic colorectal cancer in Western patients, this study is designed to compare S-1 and capecitabine monotherapy in terms of safety, with particular interest in HFS, in metastatic colorectal cancer patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||S1 Versus Capecitabine in the First Line Treatment of Metastatic Colorectal Cancer Patients, the SALTO Randomised Phase III Study of the Dutch Colorectal Cancer Group. A Safety Evaluation of Oral Fluoropyrimidines|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2018|
Active Comparator: Capecitabine
Capecitabine 1250 mg/m2 for patients < 70 years of age, and 1000 mg/m2 for patients ≥ 70 years of age, orally b.i.d. day 1-14 with or without bevacizumab 7.5 mg/kg i.v. day 1.
Other Name: Xeloda
Other Name: Avastin
S-1 30 mg/m2 orally b.i.d. irrespective of age, day 1-14 with or without bevacizumab 7.5 mg/kg i.v. day 1.
Other Name: S1
Other Name: Avastin
- Incidence of HFS in first line treatment [ Time Frame: HFS will be assessed every 3 weeks up to 6 months average. ]To determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer.
- Grade 3 HFS [ Time Frame: HFS will be assessed every 3 weeks, up to 6 months average ]Incidence of grade 3 hand-foot syndrome, according to CTC 4.0.
- Progression-free survival [ Time Frame: Every 9 weeks, for 6 months (average) ]Time from randomisation until progression or death whichever comes first
- Overall toxicity [ Time Frame: Every 3 weeks, for 6 months (average) ]Adverse events graded accoording to the NCI CTCAE version 4
- Overall survival [ Time Frame: 2 years ]From date of randomisation to death or last known to be alive
- Response rate [ Time Frame: Response will be assessed every 9 weeks, up to 6 months average. ]Response acccording to RECIST 1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918852
|Medisch Centrum Alkmaar|
|Meander Medisch Centrum|
|Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis|
|Amsterdam, Netherlands, 1066 CX|
|Academic Medical Centre|
|Bergen op Zoom, Netherlands|
|Medisch Spectrum Twente|
|Medisch Centrum Leeuwarden|
|Sint Franciscus Gasthuis|
|Orbis Medisch Centrum|
|University Medical Centre Utrecht|
|VieCuri Medisch Centrum|
|Zaans Medisch Centrum|
|Principal Investigator:||Cornelis JA Punt, Prof MD PhD||Amsterdam Medical Centre|