Colorectal Cancer
Conditions
Interventions
TS-1 80mg/m2/day (day1-14) and Oxaliplatin 130mg/m2 (day1) and Bevacizumab 7.5mg/kg (day1) every 21 days for 4 courses followed by TS-1 80mg/m2/day (day1-14) and Bevacizumab 7.5mg/kg (day1) every 21 d
Sponsors
Uwajima City Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed Colorectal Cancer(Adeno Carcinoma) 2)Stage IV and chemotherapy naive patients 3) aged 20 years or older 4)Performance Status(ECOG):0-1 5)Oral intake is possible 6)Adequate organ functions 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Contraindication of TS-1, Oxaliplatin and Bevacizumab. 2)Patients with severe complications,(heart failure, renal failure, liver failure, peptic ulcer hemorrhage, intestinal paralysis, intestinal obstruction, Peritonitis or uncontrollable diabetes mellitus or hypertension) 3)Patients with History of severe drug allergy, pulmonary fibrosis, interstitial pneumonitis, Thrombosis/embolism, Cerebral infarction, pulmonary infarction or hemoptysis. 4)Patients with severe diarrhea 5) Patients with sensory neuropathy 6)Patients with serious infections or susupected infections with fever(over 38 degree) 7)HBs Ag is positive 8)Complication of ascites or pleural effusion requiring treatment such as the drainage 9) Patients with the primary tumor with the high-grade stenosis as an endoscope do not pass.( However, the case of excision of the primary tumor or the stoma is possible.) 10) Patients with the peritoneal metastasis which we can confirm with an image 11)concomitant therapy with flucytocine, phenytoin or warfarin 12)Pregnant, breast feeding, or men in hope of Pregnancy of partner. 13)Relapse of administering period and less than 6 months of TS-1 or Oxaliplatin. 14) Patients with the continuous systemically administration of steroid. 15) Active concomitant malignancy with less than five years in disease free interval. 16)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Response Rate, Safety | — |
Countries
Japan
Contacts
Public ContactYoshinori Imai
Uwajima City Hospital Surgery
Outcome results
None listed