Colorectal cancer
Conditions
Interventions
XELOX+BEV Capecitabine:2000mg/m2 d1-14 Oxaliplatin:130mg/m2 d1 Bevacizumab:7.5mg/kg d1 Q3w Discontinuation of oxaliplatin when neurotoxicity develops >
=Grade2
Sponsors
Yokohama City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histological confirmation of adenocarcinoma. (2)Advanced or recurrent colorectal cancer who are not candidate for curative resection.(six months after adjuvant chemotherapy is included) (3)Presence of evaluable lesions as confi rmed by CT or MRI;no previous chemo therapy or radiotherapy (4)Age of 70 years or older. (5)ECOG performance status of 0-2. (6)Adequate organ function according to following laboratory values obtained within 14 days before enrolment (Data recorded nearest to the entry should be referred. And excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) 1)WBC>=3,000/mm3 2)Neu>=1,500/mm3 3)Pt>=7.5*10^4 /mm3 4)Hb>=8.0 g/dL 5)T-bil<=1.5mg/dl 6)AST and ALT <=100IU/l (Liver metastasis =< 200IU/l) 7)sCr <=Institution standard value*1.5 8)Proteinuria <=1+ (7)Written informed consent after receiving explanation of planned treatments in the study
Exclusion criteria
Exclusion criteria: (1)Complication of cerebrovascular disease or the symptoms within 1year. (2)Invasive assessment within 4 weeks prior to enrollment in the study or aspiration biopsy cytology within 1 week. (3)Untreated traumatic bone fracture (4)Sever or uncontrolled complications (Peptic ulcer,hypertention,diarrhea,infections, gastrointestinal perforation,intestinal pneumonia,pulmonary fibrosis). (5)Bleeding tendency(hemoptysis,including central necrosis/cavitation of lung metastasis)coagulopathy (6)Receiving anticoaglant drugs within 14 days. (7)Thrombosis,thromboembolism,or receiving anticoagulant drugs(except aspirin under 325mg/day) (8)Cardiac disease with symptom or treatment(>=Grade2,NCI-CTCAE).Cardiac infarction within 1 year. (9)Massive pleural effusion or peritoneal fluid (10)History of active double cancer within 5 years.(Digestive cancer carcinoma in situ of the cervix and skin basal cell carcinoma, or by endoscopic mucosal resection endoscopic, healing has been confirmed, transition is not observed overlap cancer of less than five years was except for the prostate cancer) (11)Neuropathy of grade 1 or more Ver.3.0 Japanese translation JCOG/JSCO version NCI-CTCAE (12)A history of organ transplantation requiring immunosuppressive agents. (13)Oxaliplatin, or with a history of hypersensitivity to severe capecitabine (14)Suspected (DPD) deficiency dihydropyrimidine dehydrogenase, adverse reactions to fluoropyrimidine drugs was expressed. (15)Active hepatitis B virus infection(HBc Ab(+) or HBV-DNA(+)) (16)Investigator deems inappropriate to participate in the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Grade3 neuropathy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Progression free survival, Overall survival, Rate of adverse events, PNQ, EORTC QLQ-C30 | — |
Countries
Japan
Contacts
Public ContactAtsushi Ishibe
Yokohama City University Hospital gastroenterological surgery
Outcome results
None listed