advanced colorectal cancer
Conditions
Interventions
Patients receive XELOX(+BEV) for 4 cycles, they then receive XEL+BEV until PD, they finally receive XELOX(+BEV) until PD.
Sponsors
SGCSG: Shimane Gastroenterological Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histological confirmation of colorectal cancer. (2)Written informed consent. (3)20 years old or more when received informed consent. (4)Eastern Cooperative Oncology Group (ECOG) Performance Status(PS):0-2. (5)Life expectancy estimated 3 months, and more. (6)Measurable lesions in RECIST criteria (ver.1.1) is needed. (7)Patients with metastatic colorectal cancer who had received no previous therapy.Previous adjuvant treatment is allowed if it is completed at least 6 months before registration. (8)Patients with advanced colorectal cancer who had received no intervention expect surgical procedure(R0 surgery is not included). (9)Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site. (10)Vital organ functions (listed below) are preserved within 14 days prior to entry. 1. White blood cell count >= 4,000 /mm3 2. Platelets >= 100,000 /mm3 3. Hemoglobin >= 9.0 g/dL 4. Total bilirubin >= 1.5 mg/dL 5. AST,ALT <= 100 IU(<= 200 IU in liver metastases case) 6. Serum creatinine <= upper limit of normal (ULN) 7. Urinary protein <= Grade1(1+ or 0.15-1 g/24hr)
Exclusion criteria
Exclusion criteria: (1)History of the serious hypersensitivity for Capecitabine, Fluorouracil, Platinum or bevacizumab. History of the serious AE for Capecitabine or Fluorouracil by DPD Deficiency. (2)CNS metastases or brain cancer confirmed by imaging. (3)Cerebrovascular disease or its symptoms within 1 year. History of thromboembolism once within a year. (4)Synchronous malignant coelomic fluid that required drainage. (5)History of active double cancer within 5 years. (6)Necessity for antithrombotic drug. (7)Need tobadministrate or having anti-plateles therapy(including Methotrexate, aspirin and NSAIDS) (8)Symptom of gastrointestinal bleeding, intestinal paralysis, ileus, uncontrolled complication of peptic ulcer. (9)History of gastrointestinal perforation within 1 year. (10)Evidence of traumatic bone fracture. (11)Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry. (12)Uncontrolled hypertension or diabetes. (13)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (14)Evidence of interstitial lung disease or lung fibrosis. (15)Evidence of peripheral sensory neuropathy(>=Grade 1 according to NCI-CTCAE ver.4). (16)Uncontrolled infection. (17)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks. (18)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (19)Man who doesn't practice birth control. (20)Not appropriate for the study at the physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of disease control | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival,Time to Treatment Failure,Safety,Overall Response Rate,2nd Overall Response Rate,Reintroduction rate of Oxaliplatin,Overall Survival | — |
Countries
Japan
Outcome results
None listed