unresectable advanced / recurrent small bowel cancer
Conditions
Interventions
Eligible cases are assigned to the Bev + FOLFOX group or the placebo + FOLFOX group. In principle, one cycle should be 14 days, and the investigational drug (bevacizumab or placebo) should be administ
Sponsors
Yamashita Haruhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary small intestine carcinoma 2) Judged to be unresectable due to infiltration of surrounding organs or distant metastasis 3) No history of chemotherapy or radiation therapy, except postoperative adjuvant chemotherapy as long as 6 months have passed since the termination at the time of allocation 4) ECOG Performance Status score of 0 or 1 5) The age of >=20, and <=80 at the time of consent 6) Having measurable lesions 7) Having sufficient organ function i. Neutrophil count: 1,500 / micro Liter or more ii. Platelet count: 10.0 x 10^4 / micro Liter or more iii. Hemoglobin: 9.0 g / dL or more iv. Total bilirubin: 1.5 mg / dL or less v. AST, ALT: 100 IU / L (100U / L) or less for both (200 IU / L (200U / L) or less if you have liver metastasis) vi. Serum creatinine: 1.5 mg / dL or less 8) Obtained written informed consent from the patient for participation in the clinical trial
Exclusion criteria
Exclusion criteria: 1) Experienced active double cancer within 5 years 2) Having an active infection 4) Having fresh bleeding in the gastrointestinal tract 5a) Observed diarrhea that interferes with daily life 6) Having symptomatic brain metastases 8) With serious complications (intestinal palsy, interstitial pneumonia or pulmonary fibrosis, uncontrollable diabetes, heart failure, ischemic heart disease requiring treatment, uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg). 9) Those who are possibly pregnant, gave birth within 28 days, lactating, or unwilling to contraceptive 10) Judged that it is difficult to obtain informed consent due to mental illness 12a) Administered platelet aggregation inhibitors, vitamin K antagonists at therapeutic doses, or anticoagulant treatments at effective doses within 10 days prior to allocation 13) With a history of hemoptysis of 2.5 mL or more 14a) Having a high possibility for bleeding, such as tumor tissue involving major blood vessels 15a) With severe non-healing wounds, ulcers or fractures 16) Those who have experienced major surgery, with the wound not healed completely, or those whose surgery are scheduled within 28 days prior to allocation 17) Participating in other clinical trials 18) Others that the attending doctor judged inappropriate for this trial * Missing numbers: 3), 7), 11), Corrections: 5a), 12a), 14a), 15a)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - PFS as of 1 year - Overall survival (OS) - Response rate - Effective period - Effect of reducing target lesions - Disease control rate - Resection rate - Secondary cancer incidence rate - Study treatment administration period - Adverse event | — |
Contacts
Public ContactHaruhiro Yamashita
National Hospital Organization Okayama Medical Center
Outcome results
None listed