Safety and effectiveness of preoperative chemotherapy for obstructive colon cancer with endoscopic stent placement

JRCT ID: jRCTs051240077

Registered date:27/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obstructive colon cancer
• Date of first enrollment: 27/06/2024
• Target sample size: 75
• Study type: Interventional

Intervention(s)

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 clinical judgement. If administered, six courses of CAPOX are recommended and should be started after 30 days postoperatively.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Obama Kazutaka