Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery (NCT01011478) | Clinical Trial Compass
TerminatedPhase 3
Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery
United States, Canada406 participantsStarted 2010-03
Plain-language summary
RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether rosuvastatin is more effective than a placebo in treating colon cancer that was removed by surgery.
PURPOSE: This randomized phase III trial is studying rosuvastatin to see how well it works compared with placebo in treating patients with stage I or stage II colon cancer that was removed by surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patients must have the ability to swallow oral medication.
* Patients must have resected adenocarcinoma of the colon staged as American Joint Committee on Cancer (AJCC) Stage 0, I, II, or III.
* Patients must have had surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to randomization. (Laparoscopically-assisted colectomy is permitted.)
* Patients must have completed any adjuvant therapy prior to randomization.
* Patients who are taking cardioprotective low-dose aspirin at study entry must not have clinically significant toxicity, as determined by the investigator, that precludes continuation of aspirin, and the patient must be willing to continue aspirin therapy (81 mg or 325 mg) throughout study therapy.
* Colonoscopy requirements within 180 days prior to randomization:
* The patient must have either undergone a preoperative or postoperative documented colonoscopy to the cecum (or small bowel anastomosis) with adequate bowel preparation.
* All observed polyps must have been removed. (Polyps can be removed during colonoscopy or surgery performed prior to randomization.)
* Postoperative serum creatinine performed within 90 days prior to randomization must be less than or equal to 1.5 x upper limit of normal (ULN) for the lab.
* The following criteria for evidence of adequate hepatic function based on postoperative testing p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R)