Obstructive colon cancer Obstructive colon cancer, Stent
Conditions
Interventions
Two courses (6 weeks) of CAPOX as preoperative chemotherapy and elective surgery including radical colon resection with lymph node dissection.
Adjuvant chemotherapy will be administered under the clin
Neoadjuvant Therapy
Sponsors
Obama Kazutaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with primary obstructive colorectal cancer from cecum to RS rectum 2. Endoscopic stent placement (including emergency / semi-emergency) 3. clinical Stage II or III (excluding cT4b) 4. 18 years old and over, under 80 years old 5. ECOG-PS is 0 or 1 6. Successful clinical status on blood test and CT evaluation 1-2 weeks after stent placement clinically successful status: no perforation, unobstructed, stable general condition 7. Maintained major organ function 8. Written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Distant metastasis (cM1) or invasion of other organs (cT4b) on CT 2. Pathologically diagnosed as other than adenocarcinoma 3 Active overlapping cancers (synchronous overlapping cancers or metachronous overlapping cancers with a disease-free period of 5 years or less) 4. Chemotherapy or radiation therapy within the last 6 months 5. Continuous systemic administration of steroids or other immunosuppressive drugs 6. Serious comorbidities (unstable angina, heart failure, chronic lung disease, bleeding ulcers, poorly controlled diabetes, epilepsy, psychiatric disorders, etc) 7. Decompression procedures other than colonic stents (nasal/anal ileus tubes) 8. Pregnant or possibly pregnant 9. Other patients who are judged to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative severe complication rate The proportion of patients with Clavien-Dindo Grade III or higher stent-related complications and postoperative complications from the time of enrollment to 30 days postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events due to chemotherapy Protocol completion rate Stoma construction rate R0 resection rate Pathological response rate 2-year Overall survival 2-year Relapse free survival 2-year distant metastasis rate Exploring risk factors | — |
Contacts
Public ContactRyosuke Mizuno
Kyoto University Graduate School
Outcome results
None listed