A Phase 3 interventional study of Capecitabine and Teysuno in Colorectal Cancer and Metastases, sponsored by Dutch Colorectal Cancer Group. Completed at 24 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by Dutch Colorectal Cancer Group · Phase 3, Interventional, and Treatment
The study is a two-arm randomised phase III trial. Patients will be randomised to receive capecitabine (arm A) or S-1 (arm B). Bevacizumab may be added according to the choice of the investigator. Patients will be followed 3-weekly at the outpatient clinic, toxicity will be assessed according to study protocol guidelines. Patients will be evaluated every 3 cycles for response. Upon disease progression patients will be treated according to the local investigators
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 161 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
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.
Drug: Capecitabine · Drug: Bevacizumab
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.
Drug: Teysuno · Drug: Bevacizumab
Also known as: Xeloda
Also known as: S1
Also known as: Avastin
Incidence of HFS in first line treatment
To determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer.
Time frame: HFS will be assessed every 3 weeks up to 6 months average.
Grade 3 HFS
Incidence of grade 3 hand-foot syndrome, according to CTC 4.0.
Time frame: HFS will be assessed every 3 weeks, up to 6 months average
Progression-free survival
Time from randomisation until progression or death whichever comes first
Time frame: Every 9 weeks, for 6 months (average)
Overall toxicity
Adverse events graded accoording to the NCI CTCAE version 4
Time frame: Every 3 weeks, for 6 months (average)
Overall survival
From date of randomisation to death or last known to be alive
Time frame: 2 years
Response rate
Response acccording to RECIST 1.1
Time frame: Response will be assessed every 9 weeks, up to 6 months average.
Plan to share: Undecided
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Dutch Colorectal Cancer Group