colorectal cancer
Conditions
Interventions
For 3 years after surgery, physical examination, tumor marker test every 6 months, and annual chest and abdominal CT scan.
After 3 years after the surgery, physical examination, tumor marker test, and
Sponsors
Kanemitsu Yukihide
Eligibility
Sex/Gender
All
Inclusion 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, (b) Tumor budding: BD3, (c) Perineural invasion: Pn1, (d) Desmoplastic reaction (DR) category: intermediate/immature 8) Age at registration is of 20 to 75 years old. 9) ECOG Performance status is 0 or 1. 10) No prior chemotherapy or radiotherapy to the abdomen or pelvis. 11) Witten informed consent is obtained
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS), Local relapse-free survival (LRFS), Disease-free survival (DFS) | — |
Contacts
Public ContactYukihide Kanemitsu
National Cancer Center Hospital
Outcome results
None listed