S-1 een oraal middel succesvol bij alvleesklierkanker wordt in fase III studie in Nederland onderzocht bij dikke darmkanker

9 januari 2018: lees ook dit artikel:

https://kanker-actueel.nl/s-1-plus-irinotecan-plus-bevacizumab-versus-mfolfox6-of-capeox-plus-bevacizumab-voor-uitgezaaide-darmkanker-geeft-betere-overall-overleving-en-minder-bijwerkingen.html

29 januari 2017: Zie ook dit artikel:

https://kanker-actueel.nl/NL/s-1-iris-een-oraal-in-te-nemen-chemo-geeft-minder-vaak-en-minder-ernstig-hand-en-voetsyndroom-bij-behandeling-van-vergevorderde-darmkanker.html

8 oktober 2013: Bron: Clinical trials

Al eerder melden we de uitstekende resultaten van S-1 bij alvleesklierkanker, maar nu is ook in Nederland, aanmelden via trialbureau in Nijmegen, een fase III studie gestart bij dikke darmkanker met S-1 in vergelijking met Xeloda - capecitabine. Een verheugende ontwikkeling. Als u hier klikt kunt u het hele protocol lezen van deze studie. Neem dit mee naar uw behandelend oncoloog als u denkt hiervoor in aanmerking te komen en dan kunt u via hem of haar zich aanmelden voor de studie.

Telephone number	0031243616837
B.5.5	Fax number	0031243619080
B.5.6	E-mail	trialbureau@iknl.nl

De belangrijkste criteria voor deelname aan de Salto studie zijn:

S-1 (Teysuno®) versus capecitabine met of zonder bevacizumab, als eerstelijns behandeling bij patiënten met uitgezaaide dikkedarmkanker. Een studie van de Dutch Colorectal Cancer Group

Main objective of the trial

To determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer.

E.2.2

Secondary objectives of the trial

• Incidence of grade 3 hand-foot syndrome
• Incidence of other toxicities
• Progression-free survival
• Response rate
• Overall survival

E.2.3

Trial contains a sub-study

E.3

Principal 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.

En de uitsluitingscriteria zijn:

• 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 <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.
• Chronic active infection.
• Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs.
• Any impairment of gastrointestinal function or –disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea (defined as ³CTC grade 2), malabsorption syndrome, bowel obstruction, or inability to swallow tablets).
• Concomitant treatments: concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation; concurrent treatment with any other anti-cancer therapy.
• Continuous use of immunosuppressive agents (except the use of corticosteroids as anti-emetic prophylaxis/treatment).

In case of treatment with bevacizumab:
• Uncontrolled hypertension, i.e. consistently > 150/100 mmHg.
• Use of ≥ 3 antihypertensive drugs.