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

NCT07012538 | Completed

• 1 other identifier: RAIPC
• Study Type: observational
• Target: 2,640
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

renin-angiotensin system inhibitor; colon cancer; disease-free survival

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years after surgery

Other Outcomes (1)

• 3-year overall survival

  3 years after surgery

Study Arms (2)

Renin-angiotensin system inhibitors (RASi)

Using RASi after radical resection of stage II/III colon cancer

Drug: Renin-angiotensin system inhibitors (RASi)

No renin-angiotensin system inhibitors (No RASi)

Not using RASi after radical resection of stage II/III colon cancer

Drug: No renin-angiotensin system inhibitors (No RASi)

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.

Renin-angiotensin system inhibitors (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.

No renin-angiotensin system inhibitors (No RASi)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertension and stage II/III colon cancer, received radical resection of the primary tumor.

You may qualify if:

• Inferior tumor edge \> 15 cm from anal verge;
• Received radical resection of primary tumor;
• Pathological proved stage II or stage III adenocarcinoma;
• 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;
• Combined with hypertension at time of surgery;
• No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
• Informed consent.

You may not qualify if:

• Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
• Multiple primary colorectal cancer;
• Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
• Co-existent inflammatory bowel disease;
• Pregnancy or lactation;
• Received any of preoperative anti-cancer treatment.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongshan Hospital Fudan University

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 10, 2025
• Study Start: January 4, 2012
• Primary Completion: December 30, 2021
• Study Completion: April 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Locations

CN (1)