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The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial

The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial - SOAC-1102(WSTAR)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007697
Enrollment
130
Registered
2012-04-10
Start date
2011-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

1st line chemotheraypy: SOX+Bmab Bmab: 7.5mg/kg every 3weeks L-OHP: 130mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 2nd line chemotheraypy: SIR+Bmab Bmab: 7.5mg

Sponsors

Chiba surgical oncology development association
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Confirmed adenocarcinoma 2) Unresectable colon or rectal cancer 3) 20 >=, <80 years old 4) Performance status(ECOG): 0-1 5) Evaluable lesion by CT, MRI and X-ray within 30 days 6) No previous treatment 7) No abnormally electrocardiogram 8) Oral intake is possible 9) Adequate organ fanction 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Serious drug hypersensitivity 2) Pregnant or nursing 3) Active infection 4) Serious coexisting illness diabetes mellitus, uncontrolled or controlled with insulin, uncontrolled hypertension, liver cirrhosis, renal disfaunction, severe pulmonary dysfunction, active infection, history of myocardial infarction 5) Gastrointestinal ulcer or bleeding 6) Sensory neuropathy 7) Hydrothorax or ascites which needs treatment 8) Brain metastasis 9) Gastrointestinal perforation within 6 months 10) Cerebral infarction, myocardial infarction, pulmonary infarction and interstitial pneumonia 11) Operation within 28 dys 12) Congenital bleeding factor 13) Anticoagulation drugs are given to 14) Active synchronous or metachronous malignancy other than carcinoma in situ 15) Past of the hemoptysis 16) Case having the primary lesion genesis with high stenosis 17) The case that peritoneum dissemination or a peritoneum nodule is confirmed with an image 18) Case taking Flucytosine or Atazanavir Sulfate 19) Diarrea 20) Choloplania 21) The continuous case that receive it systematically of the steroid 22) Atopic dermatitis 23) Not suitable for participating in the study for any other reason

Design outcomes

Primary

MeasureTime frame
Overall survival:OS

Countries

Japan

Contacts

Public ContactHideaki Miyauchi

Chiba surgical oncology development association The secretariat

miyahide@faculty.chiba-u.jp043-226-2110

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026