A phase II study of preoperative concurrent chemoradiotherapy with TS-1/ Oxaliplatin in patients with locally advanced rectal cancer(PerSeUS-RC01)
- Conditions
- locally advanced rectal cancer
- Registration Number
- JPRN-UMIN000011861
- Lead Sponsor
- PerSeUS:Perpetual Study estimated-by United Sections in Gifu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1) History of Severe drug allergy 2) Active infections (over 38.0 degree) 3) Severe concurrent disease (interstitial pneumonitis or pulmonary fibrosis, poorly controlled diabetes, renal failure or hepatic failure) 4) Severe aberration of electrocardiogram, schemic heart disease, arrhythmia, cardiac infarction or heart failure. 5) Sensory neuropathy 6) Watery diarrhea 7) Massive pleural effusion or ascites 8) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less) 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 10) Current use of flucytosine 11) Positive hepatitis-B antigen 12) Physician concludes that the patient's participation in this trial is inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological effect
- Secondary Outcome Measures
Name Time Method Pathological complete response rate R0 resection rate Disease free survival Overall survival Local recurrence rate Distant recurrence rate Safety Relative Dose Intensity