Unresectable Stage IV colorectal cancer and a synchronous symptomatic primary tumor
Conditions
Interventions
A: Open primary tumor resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab
CapeOX: bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m2 as a 2-hour IV on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks)
B: Laparoscopic primary tumo
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 3. Primary tumor with bowel stenosis (no obstruction) and/or bleeding (Hb<9.0 or blood transfusion within 4 weeks). If emergency operation is needed, the patient is ineligible. 4. 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 enlargement 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 5. No apparent invasion to adjacent organs 6. No ascites above the pelvic cavity 7. Neither bone metastases nor brain metastases 8. No history of abdominal surgery 9. PS of 0, 1, or 2 10. Aged 20 to 74 years 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) AST=<100IU/L (4) ALT=<100IU/L
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) HBs antigen positive 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 6 months 13) Unstable angina pectoris, previous myocardial infarction, or arterial thrombotic event within 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 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, proportion of conversion from laparoscopic surgery to open surgery, proportion of patients who fulfill the criteria of starting chemotherapy by 6 weeks after operation, intraoperative and postoperative complication, adverse events during chemotherapy, serious adverse events | — |
Countries
Japan
Contacts
Public ContactTomonori Akagi, Masafumi Inomata
JCOG1107 Coordinating Office First Surgery, Oita University Faculty of Medicine
Outcome results
None listed