Neoadjuvant chemotherapy for left-sided obstructive colon cancer after decompression

JRCT ID: jRCTs021230067

Registered date:29/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: left-sided obstructive colorectal cancer
• Date of first enrollment: 29/03/2024
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Preoperative chemotherapy:
Two courses of CAPOX therapy after SEMS or stoma decompression.

Surgery:
Surgery is performed as soon as the patient has recovered from the adverse events of chemotherapy.

Postoperative chemotherapy:
Six courses of CAPOX therapy will be given to patients at high risk of recurrence, and two courses of CAPOX therapy will be given to patients at low risk.

Outcome(s)

• Primary Outcome: 3 year disease-free survival rate
• Secondary Outcome: Preoperative chemotherapy completion rate, preoperative chemotherapy adverse event rate, R0 rate, postoperative chemotherapy completion rate, postoperative chemotherapy adverse event rate, complication rate after primary tumor resection, complication rate after stoma closure, 3 year permanent stoma rate, 3 year local recurrence rate, 3 year overall survival rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically proven colorectal adenocarcinoma.
2) The lower margin of the tumor is D, S, or RS.
3) It is confirmed to be inability to pass scope during colonoscopy and be CROSS 0-1 before decompression.
4) Successful decompression with stent or stoma.
5) Eastern Cooperative Oncology Group performance status (PS) 0-1.
6) Age at enrollment is 18 years or older.
7) Adequate hematological, hepatic, renal and metabolic function parameters.
8) Written informed concent.

Exclude criteria

1) Invasion to other organs.
2) Distant metastasis.
3) CT after decompression shows residual obstructive colitis or abscess formation.
4) Active multiple carcinomas (intraepithelial carcinoma is acceptable).
5) Bone marrow suppression (neutrophil count <1,500/mm3, platelet count <100,000/mm3).
6) Severe renal impairment (creatinine clearance* <30 mL/min).
7) Prior chemotherapy for the subject disease.
8) Previous radiotherapy in the pelvic region.
9) Drug sensitivity to study medications.
10) History of major surgery (implantable central venous reservoir placement and stoma placement are acceptable) within 28 days prior to enrollment.
11) History of clinically severe cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment.
12) Severe complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.)
13) Pregnant woman, lactating woman, a woman who intends to be pregnant or a man whose partner wishes to become pregnant.
14) Other cases deemed by the investigator to be inappropriate for the safe conduct of this study.

Related Information

• Primary Sponsor: Miura Takuya