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Colorectal CancerPhase 3SALTONCT01918852

S-1 Versus Capecitabine in the First Line Treatment of MCC Patients.

A Phase 3 study testing Capecitabine, Teysuno and Bevacizumab in people with Colorectal Cancer and Metastases, run by Dutch Colorectal Cancer Group at 24 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastases
What is being tested?
Capecitabine, Teysuno and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
24 sitesNetherlands
Study dates
Dec 2013to Mar 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Netherlands24 sites

  • Medisch Centrum Alkmaar

    Alkmaar

  • Meander Medisch Centrum

    Amersfoort

  • Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • Academic Medical Centre

    Amsterdam

  • OLVG

    Amsterdam

  • VUMC

    Amsterdam

  • Wilhelmina Ziekenhuis

    Assen

  • Ziekenhuis Lievensberg

    Bergen op Zoom

  • Amphia Ziekenhuis

    Breda

  • Slingeland Ziekenhuis

    Doetinchem

  • Catherina Ziekenhuis

    Eindhoven

  • Medisch Spectrum Twente

    Enschede

  • St Jansdal

    Harderwijk

  • Spaarne Ziekenhuis

    Hoofddorp

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Antonius Ziekenhuis

    Nieuwegein

  • Waterland Ziekenhuis

    Purmerend

  • Sint Franciscus Gasthuis

    Rotterdam

  • Vlietland Ziekenhuis

    Schiedam

  • Orbis Medisch Centrum

    Sittard

  • Tweesteden Ziekenhuis

    Tilburg

  • University Medical Centre Utrecht

    Utrecht

  • VieCuri Medisch Centrum

    Venlo

  • Zaans Medisch Centrum

    Zaandam

Other trials in Netherlands

About this study

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

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

Read the detailed description

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.

Being tested
Capecitabine, Teysuno, Bevacizumab
Keywords
Hand-foot syndrome, Toxicity, Fluoropyrimidine, Capecitabine, Teysuno, S1
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Hand-Foot Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01918852
Study groupRoleWhat they receive
CapecitabineActive comparatorCapecitabine 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.
Receives: Drug: Capecitabine; Drug: Bevacizumab
S1ExperimentalS-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.
Receives: Drug: Teysuno; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: HFS will be assessed every 3 weeks up to 6 months average.

Secondary outcomes (5)

  1. Grade 3 HFS

    Incidence of grade 3 hand-foot syndrome, according to CTC 4.0.

    Measured: HFS will be assessed every 3 weeks, up to 6 months average

  2. Progression-free survival

    Time from randomisation until progression or death whichever comes first

    Measured: Every 9 weeks, for 6 months (average)

  3. Overall toxicity

    Adverse events graded accoording to the NCI CTCAE version 4

    Measured: Every 3 weeks, for 6 months (average)

  4. Overall survival

    From date of randomisation to death or last known to be alive

    Measured: 2 years

  5. Response rate

    Response acccording to RECIST 1.1

    Measured: Response will be assessed every 9 weeks, up to 6 months average.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2015
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01918852
Sponsor's protocol ID
SALTO
Acronym
SALTO
Status last verified
Mar 2018
First submitted
24 Jun 2013
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Kwakman JJM, van Werkhoven E, Simkens LHJ, van Rooijen JM, van de Wouw YAJ, Tije AJT, Creemers GM, Hendriks MP, Los M, van Alphen RJ, Polee MB, Muller EW, van der Velden AMT, van Voorthuizen T, Koopman M, Mol L, Punt CJA. Updated Survival Analysis of the Randomized Phase III Trial of S-1 Versus Capecitabine in the First-Line Treatment of Metastatic Colorectal Cancer by the Dutch Colorectal Cancer Group. Clin Colorectal Cancer. 2019 Jun;18(2):e229-e230. doi: 10.1016/j.clcc.2019.01.002. Epub 2019 Jan 29. No abstract available.

    PubMed 30782413

  • Kwakman JJM, Simkens LHJ, van Rooijen JM, van de Wouw AJ, Ten Tije AJ, Creemers GJM, Hendriks MP, Los M, van Alphen RJ, Polee MB, Muller EW, van der Velden AMT, van Voorthuizen T, Koopman M, Mol L, van Werkhoven E, Punt CJA. Randomized phase III trial of S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer: SALTO study by the Dutch Colorectal Cancer Group. Ann Oncol. 2017 Jun 1;28(6):1288-1293. doi: 10.1093/annonc/mdx122.

    PubMed 28383633

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine, Teysuno and Bevacizumab in people with Colorectal Cancer and Metastases, run by Dutch Colorectal Cancer Group at 24 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of HFS in first line treatment (time frame: HFS will be assessed every 3 weeks up to 6 months average.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01918852, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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