S-1 Versus Capecitabine in the First Line Treatment of MCC Patients. (SALTO)
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| ClinicalTrials.gov Identifier: NCT01918852 |
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Recruitment Status :
Completed
First Posted : August 8, 2013
Last Update Posted : March 14, 2018
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| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Capecitabine
Other Name: Xeloda Drug: Bevacizumab Other Name: Avastin |
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Experimental: S1
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.
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Drug: Teysuno
Other Name: S1 Drug: Bevacizumab 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 treatment with fluoropyrimidine monotherapy with or without bevacizumab.
- WHO performance status 0-2 (Karnofsky PS ≥70%)
- 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.
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 previous systemic treatment for metastatic disease.
- History or clinical signs/symptoms of CNS metastases.
- History of a second malignancy <5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.
- Previous intolerance of capecitabine.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency or treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.
- Planned radical resection of metastases after downsizing by systemic treatment.
- Significant cardiovascular disease < 1 yr before randomisation (symptomatic congestive heart failure, myocardial ischemia or infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event, pulmonary embolism).
- Any significant cardiovascular events during previous fluoropyrimidine therapy.
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
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| Principal Investigator: | Cornelis JA Punt, Prof MD PhD | Amsterdam Medical Centre |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dutch Colorectal Cancer Group |
| ClinicalTrials.gov Identifier: | NCT01918852 |
| Other Study ID Numbers: |
SALTO |
| First Posted: | August 8, 2013 Key Record Dates |
| Last Update Posted: | March 14, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Hand-foot syndrome Toxicity Fluoropyrimidine |
Capecitabine Teysuno S1 |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab |
Capecitabine Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |