RASi for Preventing Postoperative Recurrence of Stage II/III Colon Cancer

Fudan University2,640 enrolled

Overview

The goal of this retrospective cohort study is to learn about the long-term effects of renin-angiotensin system inhibitors (RASi) in preventing patients with hypertension and stage II/III colon cancer from recurrence and metastases after radical resection. The main question it aims to answer is: Does RASi improve the 3-year disease-free survival of patients with hypertension and stage II/III colon cancer after surgery? Participants with hypertension and already having radical resection of stage II/III colon cancer will be followed up for 3 years.

Previous studies have shown that renin-angiotensin system inhibitors (RASi) may reduce postoperative recurrence and metastases of colorectal cancer. However, the relevant clinical evidences were low level and controversial. This study retrospectively collect patients with hypertension and stage II/III colon cancer after radical resection, and compare the patients with vs. without RASi in terms of long-term oncological outcomes, to study the inhibitory effect of RASi on recurrence and metastasis.

Study Type

OBSERVATIONAL

Enrollment

2,640

Conditions

Colon Cancer (Stage II &Amp;Amp; III)

Interventions

Renin-angiotensin system inhibitors (RASi)DRUG

Using RASi after radical resection of stage II/III colon cancer for at least 3 years or till recurrence or death or inappropriate use of RASi.

No renin-angiotensin system inhibitors (No RASi)DRUG

Not using RASi after radical resection of stage II/III colon cancer for at least 3 years or till recurrence or death or needing RASi.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Inferior tumor edge \> 15 cm from anal verge; 2. Received radical resection of primary tumor; 3. Pathological proved stage II or stage III adenocarcinoma; 4. No evidence of distant metastases at time of surgery (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, intraoperative exploration, etc; 5. Combined with hypertension at time of surgery; 6. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; 7. Informed consent. Exclusion Criteria: 1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc; 2. Multiple primary colorectal cancer; 3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.); 4. Co-existent inflammatory bowel disease; 5. Pregnancy or lactation; 6. Received any of preoperative anti-cancer treatment.

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

3-year disease-free survival

The events of 3-year disease-free survival are defined as any recurrence of metastases or death within 3 years after surgery.

Time frame: 3 years after surgery

Data from ClinicalTrials.gov

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