NCT01349881|Active Not RecruitingPhase 3DMC

S0820, Adenoma and Second Primary Prevention Trial

PACES

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S0820U10CA037429NCI-2012-02067

Study Type

interventional

Target

354

Locations

1 country

Sites

990

Timeline

RegisteredMay 2011

StartedAug 2013

CompletionFeb 2032

Brief Summary

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

354

participants targeted

Target at P50-P75 for phase_3

Timeline

70mo left

Started Aug 2013

Longer than P75 for phase_3

Geographic Reach

1 country

990 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

18.5 years study duration

Study Progress69%

Aug 2013Feb 2032

First Submitted

Initial submission to the registry

May 5, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed

2.3 years until next milestone

Study Start

First participant enrolled

August 23, 2013

Completed

14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2032

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

14.1 years

First QC Date

May 5, 2011

Last Update Submit

April 1, 2026

Conditions

Colorectal Neoplasms

Keywords

Eflornithine/sulindac prevention trial

Outcome Measures

Primary Outcomes (1)

Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)
High risk adenoma is defined as either advanced adenoma (villous or tubulovillous histology, size \>= 1 cm, or high grade dysplasia) or multiple adenomas (3 or more each \> 0.3 cm). The primary analysis of the 3-year event rate will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A two-arm binomial design without continuity correction will be used.
3 years after registration

Secondary Outcomes (15)

Total advanced colorectal event rate, defined as the number of patients with at least one high risk adenoma, second primary CRC, CRC recurrence, or metastasis
Up to 8 years
Colon cancer recurrence
Up to 8 years
High-grade dysplasia
Up to 8 years
Adenomas with villous features, defined as villous histology (villous and tubulovillous adenomas)
Up to 8 years
Adenomas >= 1 cm
Up to 8 years
+10 more secondary outcomes

Study Arms (4)

eflornithine placebo & sulindac placebo

PLACEBO COMPARATOR

Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.

Drug: Eflornithine placebo & sulindac placebo

Eflornithine & sulindac placebo

EXPERIMENTAL

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one tablet PO daily for 3 years.

Drug: eflornithine & sulindac placebo

Eflornithine placebo & sulindac

EXPERIMENTAL

Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Drug: Eflornithine placebo & sulindac

Eflornithine plus sulindac

EXPERIMENTAL

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Drug: Eflornithine plus sulindac

Interventions

Eflornithine placebo & sulindac placeboDRUG

Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years

eflornithine placebo & sulindac placebo

eflornithine & sulindac placeboDRUG

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.

Eflornithine & sulindac placebo

Eflornithine placebo & sulindacDRUG

Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Eflornithine placebo & sulindac

Eflornithine plus sulindacDRUG

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Eflornithine plus sulindac

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
Post-operative colonoscopy and CT scans of chest, abdomen \& pelvis showing no evidence of disease
Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C \>/= 190 mg/dL or triglycerides \>/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure \> 150 mm Hg) within 28 days prior to registration
At least 30 days from completion of adjuvant chemo and RT.
Presence of gastroesophageal reflux disease acceptable if controlled with medications
Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis. NSAID use must not exceed 10 days per month; Maximum aspirin dose
mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.
Able to swallow oral medications
Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin \> 11.0 g/dL. (A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥ 3.4 x 1000/mcL for non-Hispanic black females. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
Zubrod PS 0-1, 18 years of age or older
Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
Offered opportunity to participate in blood specimen banking

You may not qualify if:

History of colon resection \> 40 cm
Mid-low rectal cancer
Recurrent or metastatic disease
High cardiovascular risk; Uncontrolled hypertension
Planned radiation therapy or additional chemotherapy
Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
Significant medical or psychiatric condition that would preclude study completion (8 years)
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for \> 5 years
Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator
Cancer Prevention Pharmaceuticals, Inc.collaborator

Study Sites (990)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Alaska Breast Care and Surgery LLC