Rectal cancer
Conditions
Interventions
After 4cycle of preoperative XELOX+Bevacizumab(BV(-)at 4th cycle),primary resection is to be perfomed.Primary resection have to be done with in 4-8 weeks after last dose of Capecitabine.After resectio
Sponsors
Sano Hospital Masahito Kotaka, MD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informd consent 2.Rectal cancer with inferir edge located below peritoneal reflection,histologically adeno 3..cT2 N1,cT3 N0-1 4.20-80 years old 5.ECOG PS0-1 6.Life expect ancy from the day of eneollment is 3 months or longer 7.No prior radiotherapy 8.Major organ functions less than 14 days prior to entty meet the following criteria (Neutrophil count>=1500/mm3,Platelet count>=100.000/mm3,Hb>=9.0dl,T-Bil<=2.0mg/dl,AST ALT<=100U/L,Cre Men <1.8mg/dl female<1.35mg/d)
Exclusion criteria
Exclusion criteria: 1. Need to drain malignant coelomic fluid; 2.Multiple primary cancer within 5years 3. Bleeding tendency, coagulation factor or abnormal clotting disorder (INR 1.5) 4. Intestinal paralysis, intestinal obstruction, peptic ulcer uncontrollable 5.Serious complications (diabetes, infections, diarrhea) 6. Symptomatic or asymptomatic but treated heart disease. History of those within one year prior to enrollment 7. History of the serious hypersensitivity for fluorouracil, platinum compound. History of adverse events related to DPD loss 8. Peripheral sensory neuropathy (CTCAE v4.0 Grade 1); 9.Pulmonary fibrosis or interstitial pneumonia 10. Current or previous (within the last 1 year) history of cerebrovascular disease 11.Administered antithrombotic agents for thrombosis within 10 days prior to enrollment 12. Serious hypertension 13. History of gastrointestinal perforation 14.Pregnant women,possibly pregnant women, wishing to become pregnant, and nursing mothers; 15.No intention to practice birth control; 16.Previously treated with oxaliplatin;or capecitabine 17.Any other medical conditions disable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety(perioperative complications, adverse events by chemotherapy), 3-year recrence free survival rate, 3-year local recurrence-free survival rate, 3-year overall survival rate, R0 resection rate, pathological effect, relative dose intensity, overall response rate, down- staging rate | — |
Countries
Japan
Contacts
Public ContactMasahito Kotaka, MD
Sano Hospital Gastrointestinal Cancer Center
Outcome results
None listed