JPRN-jRCT1030220350
Recruiting
Phase 3
JCOG1915: Less intensive post-operative surveillance in low risk colorectal cancer patients - LESS study
Kanemitsu Yukihide0 sites680 target enrollmentSeptember 27, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kanemitsu Yukihide
- Enrollment
- 680
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Pathologically proven colorectal adenocarcinoma.
- •2\) Tumor is mainly located between cecum and lower rectum.
- •3\) Tumor resection with D2 or D3 lymph node dissection with open or laparoscopic approach was performed, regardless of with or without lateral lymph node dissection (Robotic surgery is allowed for enrollment).
- •4\) R0 resection was performed.
- •5\) No distant metastasis defined as
- •1\. Chest ; Chest CT or FDG\-PET/CT
- •2\. Abdomen ; Abdomen CT or FDG\-PET/CT
- •6\) 56 days after surgery.
- •7\) pStage I cancer, or pStage II cancer without any following factors (JSCCR classification 9th ed.);
- •(a) Depth of tumor: pT4,
Exclusion Criteria
- •1\) Synchronous or metachronous (within 5 years) malignancies
- •2\) Infections which needs systemic treatment.
- •3\) Severe psychological disease.
- •4\) Continuous systemic corticosteroid or immunosuppressant treatment.
- •5\) Routine thoracoabdominal and pelvic CT scan at least once a year due to past medical history / comorbidities.
Outcomes
Primary Outcomes
Not specified
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