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Completed

NCT Number: NCT07012538

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 3-year disease-free survival

    Time frame: 3 years after surgery

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

Other outcomes

  1. 3-year overall survival

    Time frame: 3 years after surgery

    The events of 3-year overall survival are defined as any death within 3 years after surgery.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Renin-angiotensin System Inhibitor for Preventing Postoperative Recurrence of Stage II/III Colon Cancer

Acronym: RAIPC

Important dates

Study start
2012
Primary completion
2021
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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