Colorectal cancer Colorectal cancer
Conditions
Interventions
Four courses of CapeOX therapy were tried preoperatively, followed by robotic rectal resection and lateral lymph node dissection.
Sponsors
Ushigome Hajime
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Histological confirmation of adenocarcinoma based on biopsy from the primary rectal tumor. 2 The lower edge of the tumor extends below the peritoneal reflection, and clinical staging is cT1-2N3 or cT3N1-3 (with N3 defined as positive lateral lymph nodes). Lymph node metastasis is defined as a short axis diameter greater than 5mm for mesorectal lymph nodes and greater than 7mm for lateral lymph nodes on CT. 3 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4 No prior treatment for rectal cancer, including radiotherapy, chemotherapy, or hormonal therapy. 5 Age between 20 and 75 years at the time of informed consent. 6 Written informed consent has been obtained after a full explanation of the study content.
Exclusion criteria
Exclusion criteria: 1 Clinical T4 tumors with suspected invasion into adjacent organs or the peritoneum, or cases in which circumferential resection margin (CRM) is expected to be positive in the primary tumor or metastatic lymph nodes, necessitating multivisceral resection in addition to total mesorectal excision (TME). 2 Contraindication to either oxaliplatin or capecitabine. 3 History of severe drug hypersensitivity. 4 History of pelvic radiation therapy. 5 Active infection accompanied by a fever of 38 degrees or higher. 6 Presence of serious comorbidities, including but not limited to congestive heart failure, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, renal failure, or hepatic failure. 7 Presence of sensory neuropathy. 8 Presence of severe diarrhea (watery stools); however, diarrhea attributable to defecatory dysfunction caused by rectal cancer itself is not considered exclusionary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pathological positive rate of lateral lymph node metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Administration rate of preoperative chemotherapy, Quality of total mesorectal excision (TME) Urinary dysfunction, R0 resection rate, Pathological complete response (pCR) rate, Tumor downstaging rate Rate of pathological lateral lymph node positivity after preoperative chemotherapy, 3-year recurrence-free survival (RFS) rate, 3-year local recurrence-free survival rate, Histological therapeutic effect assessment | — |
Contacts
Public ContactHajime Ushigome
Nagoya City University Hospital
Outcome results
None listed