A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Phase 3

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

• Registration Number: JPRN-UMIN000008147
• 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: 2012-06-12
• Study Completion: 2020-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 770

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) 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, Adverse events, proportion of R0 resection after response to chemotherapy, proportion of palliative resection in chemotherapy alone arm