Colorectal Cancer
Conditions
Interventions
None listed
Sponsors
Tochigi Cancer Center
National Hospital Organization Tokyo Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed as tubular adenocarcinoma, either well-differentiated or moderately differentiated, by endoscopic biopsy of the primary colorectal cancer lesion. 2. The main tumor location is one of the following: cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid colon, upper rectum, or lower rectum. 3. Diagnosed as cStage I disease, with a depth of invasion of cT1 to 2, based on comprehensive assessment including chest, abdominal, and pelvic CT with a slice thickness of 5 mm or less, and/or pelvic MRI. 4. No lymph node metastasis is detected. 5. No distant metastasis is detected. 6. No synchronous multiple cancers are detected based on comprehensive assessment using lower gastrointestinal endoscopy and imaging studies, including barium enema examination, abdominal/pelvic CT, or CT colonography. However, cTis or cT1a lesions, which are expected to be curatively resectable by endoscopic resection and in which the cancer is expected to remain within the submucosal layer with an invasion depth of less than 1,000 um, are not regarded as multiple cancers. 7. Age at registration is 20 years or older. 8. Performance status is 0 to 2 according to the ECOG criteria. 9. The patient is able to tolerate oral intake. 10. The patient has no history of rectal resection, excluding endoscopic resection, or pelvic radiotherapy, including treatment for other types of cancer. 11. For patients registered at Tochigi Cancer Center, enrollment is limited to cases in which consent to participate in the Tochigi Cancer Biobank has been obtained.
Exclusion criteria
Exclusion criteria: 1. The patient has active synchronous or metachronous multiple cancers. 2. The patient has lymph node metastasis. 3. The patient has distant metastasis. 4. Patients undergoing additional surgical resection after endoscopic treatment are excluded. 5. The patient has an infection requiring systemic treatment. 6. The patient is undergoing hemodialysis or has renal dysfunction, defined as a serum creatinine level exceeding the normal range at each participating institution. 7. The patient is receiving continuous systemic administration, either oral or intravenous, of corticosteroids or other immunosuppressive agents. 8. The patient has poorly controlled diabetes mellitus. 9. The patient is positive for HIV antibodies. 10. The patient has interstitial pneumonia, pulmonary fibrosis, or both, as diagnosed by chest CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CTC positivity rate in patients with early-stage colorectal cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include the associations between CTC status or CTC counts and clinicopathological factors, changes in CTC positivity rates and CTC counts before and after treatment, associations between CTC status and recurrence or prognosis, and the diagnostic performance of CTC testing. | — |
Countries
Japan
Contacts
Public ContactNaoyuki Toyota
Tochigi Cancer Center Department of Colorectal Surgery
Outcome results
None listed