Colon Cancer (Stage II &Amp;Amp; III)RAIPCNCT07012538
RASi for Preventing Postoperative Recurrence of Stage II/III Colon Cancer
An observational study of Colon Cancer (Stage II &Amp;Amp; III), run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer (Stage II &Amp;Amp; III)
- What is being tested?
- Renin-angiotensin system inhibitors (RASi) and No renin-angiotensin system inhibitors (No RASi)
- How many people
- 2,640 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2012to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypertension and stage II/III colon cancer, received radical resection of the primary tumor.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Renin-angiotensin System Inhibitor 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.
Read the detailed description
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.
- Conditions
- Colon Cancer (Stage II &Amp;Amp; III)
- Being tested
- Renin-angiotensin system inhibitors (RASi), No renin-angiotensin system inhibitors (No RASi)
- Keywords
- renin-angiotensin system inhibitor, colon cancer, disease-free survival
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Renin-angiotensin system inhibitors (RASi) | Using RASi after radical resection of stage II/III colon cancer Receives: 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 Receives: Drug: No renin-angiotensin system inhibitors (No RASi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start4 Jan 2012
- Primary completion30 Dec 2021
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer (Stage II &Amp;Amp; III)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012538
- Sponsor's protocol ID
- RAIPC
- Acronym
- RAIPC
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Whether to share the IPD will be decided after the research paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin-angiotensin System Inhibitor for Preventing Postoperative Recurrence of Stage II/III Colon Cancer
- ClinicalTrials.gov ID
- NCT07012538
- Acronym / sponsor ID
- RAIPC / RAIPC
- Conditions
- Colon Cancer (Stage II &Amp;Amp; III)
- Keywords
- renin-angiotensin system inhibitor, colon cancer, disease-free survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,640 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 4 Jan 2012 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renin-angiotensin system inhibitors (RASi) | – | Drug: Renin-angiotensin system inhibitors (RASi)Using RASi after radical resection of stage II/III colon cancer |
| No renin-angiotensin system inhibitors (No RASi) | – | Drug: No renin-angiotensin system inhibitors (No RASi)Not using RASi after radical resection of stage II/III colon cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension and stage II/III colon cancer, received radical resection of the primary tumor.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renin-angiotensin system inhibitors (RASi)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. | 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 for at least 3 years or till recurrence or death or needing RASi. | Drug | No renin-angiotensin system inhibitors (No RASi) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Undecided. Whether to share the IPD will be decided after the research paper is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer (Stage II &Amp;Amp; III), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.