A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer (JCOG1107)

Phase 3

Recruiting

• Conditions: nresectable Stage IV colorectal cancer and a synchronous symptomatic primary tumor

• Registration Number: JPRN-UMIN000009715
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-07
• Last Update Posted: 17 October 2023
• Study Completion: 2024-07-07

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
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