Unresectable Stage IV colorectal cancer and a synchronous asymptomatic primary tumor
Conditions
Interventions
A: Chemotherapy alone (mFOLFOX6 or CapeOX plus bevacizumab
CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks)
B: Primary resection followed by ch
CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically proven adenocarcinoma or adenosquamous carcinoma 2. Primary tumor located at Cecum, Ascending, Transverse, Descending, Sigmoid, Rectosigmoid, or Upper rectum 3. No bowel obstruction. 4. No active bleeding, bowel perforation, or fistula formation 5. Having at least one to up to three unresectable factors among the following four factors: 1) Hepatic metastases with the predicted remnant functional parenchyma of less than 30% 2) Pulmonary metastases meeting one of the followings: i) Invasion suspected to the mediastinum, heart, large vessels, trachea, esophagus, vertebral body, or tracheal bifurcation ii) Predicted postoperative lung function (%FEV1.0) of less than 40% iii) Requiring total pneumonectomy for removal of all metastatic tumors iv) Malignant pleural effusion or pleural dissemination 3) Distant lymph node (LN) metastases with 10 mm or greater short axis which fulfill one of the followings by CT scan: i) LN enlargement located above the lower edge of renal vein ii) LN along the common hepatic artery or the hepatoduodenal ligament with hepatic metastases iii) Mediastinal or hilar LN enlargement with pulmonary metastases 4) Peritoneal metastases meeting one of the followings: i) Multiple irregularities or strictures of the intestinal walls confirmed by imaging ii) Peritoneal tumor above the transverse colon 6. No apparent invasion to adjacent organs 7. No ascites above the pelvic cavity 8. Neither bone metastases nor brain metastases 9. PS of 0 or 1 10. Aged 20 to 74years old 11. No prior treatment of chemotherapy or radiation therapy against any other malignancies, including colorectal cancer 12. Adequate organ functions defined as below 1) Neutrophil count >=1,500/mm3 2) Platelet count >=100000/mm3 3) Hemoglobin >=9.0g/dL without any transfusion 4weeks before enrollment 4) AST=<100IU/L 5) ALT=<100IU/L 6) T.Bil=<2.0mg/dL 7) Cr=<1.5mg/dL 8) PT-INR=<1.5 13. Diarrhea and peripheral neuropathy of grade 1 or less 14. Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2) Infectious disease to be treated 3) Positive for HBs antigen 4) Body temparature >= 38c 5) Women during pregnancy, possible pregnancy or breast-feeding 6) Severe mental disease 7) Currently treated with systemic steroids 8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 9) Uncontrollable diabetes mellitus or routine administration of insulin 10) Uncontrolled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg 11) New York Heart Association class III /IV cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias 12) Gastrointestinal fistula, perforation, or abscess within the past 6 months 13) Unstable angina pectoris, previous myocardial infarction, or arterial thrombotic event within the past 6 months 14) Abdominal aortic aneurysm (>= 5cm), thoracic aortic aneurysm (>= 6cm), or aortic dissection 15) Congenital hemorrhagic diathesis, coagulation disorder, or significant episodes of acute bleeding of grade 3 or more according to CTCAE ver.4.0 within the past 28 days 16) Episodes of hemoptysis within the past 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Adverse events, proportion of R0 resection after response to chemotherapy, proportion of palliative resection in chemotherapy alone arm | — |
Countries
Japan
Contacts
Public ContactYukihide Kanemitsu
JCOG1007Coordinating Office National Cancer Center Hospital
Outcome results
None listed