Trial Outcomes & Findings for Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery (NCT NCT01011478)

Last Updated: 2023-08-16

Results Overview

Percentage of patients with occurrence of APMC+R event. APMC+R events include at least one adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

406 participants

Primary outcome timeframe

Up to 4.8 years

Results posted on

2023-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Placebo Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Overall Study STARTED	204	202
Overall Study COMPLETED	192	195
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Placebo Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Overall Study No follow up data	12	7

Baseline Characteristics

Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=204 Participants Placebo	Rosuvastatin n=202 Participants Rosuvastatin	Total n=406 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 10.3 • n=5 Participants	58 years STANDARD_DEVIATION 10.9 • n=7 Participants	58 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	108 Participants n=7 Participants	221 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	94 Participants n=7 Participants	185 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4.8 years

Population: NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Percentage of patients with occurrence of APMC+R event. APMC+R events include at least one adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=192 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=195 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R)	25.0 percentage of patients	28.2 percentage of patients

SECONDARY outcome

Timeframe: Up to 4.8 years

Population: Patients who have at least one adenoma detected. NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

The histologic size (diameter of adenoma into the wall of the colon; as per AJCC staging) of the largest adenoma among patients who have at least one adenoma detected. If histologic size was not available, the endoscopic size was provided.

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=46 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=50 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Size of Colorectal Adenomas, Including Advanced Adenomas	0.4 centimeters Interval 0.3 to 0.7	0.4 centimeters Interval 0.3 to 0.55

SECONDARY outcome

Timeframe: Up to 4.8 years

Population: NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Number of patients with DFS event (colon cancer recurrence, second primary cancer, or death from any cause)

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=192 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=195 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Disease-free Survival	17 participants with DFS event	21 participants with DFS event

SECONDARY outcome

Timeframe: Up to 4.8 years

Population: NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Number of patients with the OS event (death from any cause)

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=192 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=195 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Overall Survival (OS)	1 participants with OS event	4 participants with OS event

SECONDARY outcome

Timeframe: Up to 4.8 years

Population: NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Number of patients with the RFI event (First recurrence of colon cancer)

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=192 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=195 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Recurrence-free Interval (RFI)	12 participants with RFI event	14 participants with RFI event

SECONDARY outcome

Timeframe: Up to 4.8 years

Population: NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Number of patients with the first occurrence of non-colorectal primary cancer

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=192 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=195 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Second Non-colorectal Primary Cancer-free Interval	4 participants non-colorectal primary cx	7 participants non-colorectal primary cx

SECONDARY outcome

Timeframe: 12-month time point

Population: Patients who have submitted a 12 months QOL assessment. NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Global Quality-of-life Scale score, ranges from 0 (worst imaginable health status) to 10 (best imaginable health status.

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=70 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=62 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist	8.0 score on a scale Interval 7.0 to 9.0	8.0 score on a scale Interval 8.0 to 9.0

SECONDARY outcome

Timeframe: Up to 4.8 years

Population: Patients with available adverse event information. NOTE: No conclusions should be drawn due to insufficient number of patients randomized to the study.

Percentage of patients with at least one grade 2 or higher adverse event reported.

Outcome measures

Outcome measures
Measure	Group 1: Placebo n=191 Participants Patients receive oral placebo once daily for 5 years. placebo	Group 2: Rosuvastatin n=196 Participants Patients receive oral rosuvastatin once daily for 5 years. rosuvastatin
Toxicity Assessed by Adverse Events	41.4 percentage of patients	45.4 percentage of patients

SECONDARY outcome

Timeframe: At randomization

Population: Data on tumors and blood markers were not collected.

This study terminated early. Data on samples was not collected, the relevant analyses were not performed.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 17 serious events

Other events: 28 other events

Deaths: 0 deaths

Rosuvastatin

Serious events: 14 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=191 participants at risk Placebo	Rosuvastatin n=196 participants at risk Rosuvastatin
Gastrointestinal disorders Abdominal pain	3.7% 7/191 Participants at Risk includes any patient who submitted an AE form.	6.1% 12/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Arthralgia	9.4% 18/191 Participants at Risk includes any patient who submitted an AE form.	7.1% 14/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myalgia	7.9% 15/191 Participants at Risk includes any patient who submitted an AE form.	7.1% 14/196 Participants at Risk includes any patient who submitted an AE form.

Additional Information

Director, Department of Regulatory Affairs

NSABP Foundation

Phone: 412-339-5300

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Placebo n=191 participants at risk Placebo	Rosuvastatin n=196 participants at risk Rosuvastatin
Gastrointestinal disorders Abdominal pain	2.6% 5/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Anemia	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Aspiration	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Atrial fibrillation	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Investigations Cardiac troponin I increased	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Enterocolitis	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Endocrine disorders Hyperthyroidism	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myalgia	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Myocardial infarction	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myositis	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Nausea	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Sinusitis	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Skin infection	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Small intestinal obstruction	2.1% 4/191 Participants at Risk includes any patient who submitted an AE form.	1.0% 2/196 Participants at Risk includes any patient who submitted an AE form.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/196 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Syncope	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Thromboembolic event	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Urinary tract infection	1.0% 2/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Ear and labyrinth disorders Vertigo	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Investigations Ejection fraction decreased	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Injury, poisoning and procedural complications Wound complication	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Enterocolitis infectious	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Lung infection	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Scrotal infection	0.52% 1/191 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Ileal obstruction	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/191 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.