Colorectal NeoplasmsPhase 3PACESNCT01349881
S0820, Adenoma and Second Primary Prevention Trial
A Phase 3 study testing Eflornithine plus sulindac in people with Colorectal Neoplasms, run by SWOG Cancer Research Network at 989 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Eflornithine plus sulindac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 989 sitesUnited States
- Study dates
- 23 Aug 2013to 1 Feb 2032
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
- 100 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
989 sites in 1 country.
300 sites in 1 country
United States300 sites
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Hendrick Medical Center
Abilene, Texas, 79601
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
Bixby Medical Center
Adrian, Michigan, 49221
Hickman Cancer Center
Adrian, Michigan, 49221
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Community Hospital of Anaconda
Anaconda, Montana, 59711
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Regional Hospital
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Sutter Auburn Faith Hospital
Auburn, California, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
The Medical Center of Aurora
Aurora, Colorado, 80012
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
Rush - Copley Medical Center
Aurora, Illinois, 60504
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, 98110
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Ochsner High Grove
Baton Rouge, Louisiana, 70836
Bronson Battle Creek
Battle Creek, Michigan, 49017
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, 44122
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Beaufort Memorial Hospital
Beaufort, South Carolina, 29902
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Overlake Medical Center
Bellevue, Washington, 98004
Kaiser Permanente-Bellflower
Bellflower, California, 90706
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Gaston Hematology and Oncology Associates-Belmont
Belmont, North Carolina, 28012
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Charles Health System
Bend, Oregon, 97701
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Mac Neal Hospital
Berwyn, Illinois, 60402
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Beverly Hospital
Beverly, Massachusetts, 01915
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Saint Joseph Medical Center
Bloomington, Illinois, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
Boulder Community Hospital
Boulder, Colorado, 80301
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310
Harrison Medical Center
Bremerton, Washington, 98310
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Highline Medical Center-Main Campus
Burien, Washington, 98166
Kaiser Permanente-Burke Medical Center
Burke, Virginia, 22015
Mills-Peninsula Medical Center
Burlingame, California, 94010
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Illinois CancerCare-Canton
Canton, Illinois, 61520
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Aultman Health Foundation
Canton, Ohio, 44710
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Caro Cancer Center
Caro, Michigan, 48723
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Rocky Mountain Oncology
Casper, Wyoming, 82609
East Bay Radiation Oncology Center
Castro Valley, California, 94546
Eden Hospital Medical Center
Castro Valley, California, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
Geauga Hospital
Chardon, Ohio, 44024
Roper Hospital
Charleston, South Carolina, 29401
Charleston Oncology - Roper
Charleston, South Carolina, 29403
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, 29406
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414
Charleston Oncology - Saint Francis
Charleston, South Carolina, 29414
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina, 29414
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Novant Health Carolina Surgical - Randolph
Charlotte, North Carolina, 28207
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Southern Oncology Specialists-Charlotte
Charlotte, North Carolina, 28262
Memorial Hospital
Chattanooga, Tennessee, 37404
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Rush University Medical Center
Chicago, Illinois, 60612
Weiss Memorial Hospital
Chicago, Illinois, 60640
UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
Chicago, Illinois, 60657
Enloe Medical Center
Chico, California, 95926
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211
The Christ Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Oncology Hematology Care Inc-Anderson
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Bethesda North Hospital
Cincinnati, Ohio, 45242
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Case Western Reserve University
Cleveland, Ohio, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
University Oncology Associates
Clovis, California, 93611
Big Horn Basin Cancer Center
Cody, Wyoming, 82414
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Main Line Health Center-Collegeville
Collegeville, Pennsylvania, 19426
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mount Carmel East Hospital
Columbus, Ohio, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
The West Clinic - Corinth
Corinth, Mississippi, 38834
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, 92627
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Greater Regional Medical Center
Creston, Iowa, 50801
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
Michiana Hematology Oncology PC-Crown Point
Crown Point, Indiana, 46307
UPMC Western Maryland
Cumberland, Maryland, 21502
Parkland Memorial Hospital
Dallas, Texas, 75235
Baylor University Medical Center
Dallas, Texas, 75246
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Carle on Vermilion
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Sutter Davis Hospital
Davis, California, 95616
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
Miami Valley Hospital North
Dayton, Ohio, 45415
Beaumont Hospital - Dearborn
Dearborn, Michigan, 48124
Decatur Memorial Hospital
Decatur, Illinois, 62526
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Delaware Radiation Oncology
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
Porter Adventist Hospital
Denver, Colorado, 80210
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Rose Medical Center
Denver, Colorado, 80220
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Ascension Saint John Hospital
Detroit, Michigan, 48236
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Epic Care-Dublin
Dublin, California, 94568
Kaiser Permanente Dublin
Dublin, California, 94568
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Dublin Methodist Hospital
Dublin, Ohio, 43016
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Mercy Medical Center
Durango, Colorado, 81301
Southwest Oncology PC
Durango, Colorado, 81301
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Great Lakes Cancer Management Specialists-Doctors Park
East China, Michigan, 48054
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Easton Hospital
Easton, Pennsylvania, 18042
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017
Fairview Southdale Hospital
Edina, Minnesota, 55435
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Newman Regional Health
Emporia, Kansas, 66801
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Swedish Medical Center
Englewood, Colorado, 80113
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Providence Regional Cancer Partnership
Everett, Washington, 98201
Exeter Hospital
Exeter, New Hampshire, 03833
Main Line Health Center-Exton
Exton, Pennsylvania, 19341
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan, 48336
Virginia Mason Federal Way Medical Center
Federal Way, Washington, 98002
Saint Francis Hospital
Federal Way, Washington, 98003
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Orion Cancer Care
Findlay, Ohio, 45840
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
About this study
Official title: 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)
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.
Read the detailed description
The purpose of this study is to assess whether the combination of eflornithine 500 mg and sulindac 150 mg (compared to corresponding placebos) has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas >/= 0.3 cm, total advanced colorectal events, or total colorectal events.
- Conditions
- Colorectal Neoplasms
- Being tested
- Eflornithine placebo & sulindac placebo, eflornithine & sulindac placebo, Eflornithine placebo & sulindac, Eflornithine plus sulindac
- Keywords
- Eflornithine/sulindac prevention trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eflornithine placebo & sulindac placeboDrug
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years
eflornithine & sulindac placeboDrug
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.
Eflornithine placebo & sulindacDrug
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
Eflornithine plus sulindacDrug
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| eflornithine placebo & sulindac placebo | Placebo comparator | Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Eflornithine plus sulindac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
Colon cancer recurrence
Statistical assessments of association between the biomarker and the recurrence endpoints will be performed after converting the biomarker scores to ranks, which will facilitate detection of monotonic relationship(s).
Measured: Up to 8 years
High-grade dysplasia
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
Adenomas with villous features, defined as villous histology (villous and tubulovillous adenomas)
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
Adenomas >= 1 cm
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
Multiple adenomas, defined as 3 or more adenomas all measuring > 0.3 cm
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
The number of patients with development of any adenoma > 0.3 cm
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
Total colorectal event rate, defined as the number of patients with at least one colorectal event (advanced colorectal event or adenoma > 0.3 cm)
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: Up to 8 years
Time to first clinically apparent high-risk adenoma or second primary CRC
The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.
Measured: From date of registration to date at which high-risk adenoma or second primary CRC is detected, up to 8 years
Toxicity
Qualitative and quantitative assessment of toxicity, collected as CTCAE adverse events. Particular adverse events of interest include thrombotic cardiovascular and ototoxic events at or above a specified grade (e.g., Grade III or worse). All patients who receive any treatment will be included in the analysis of adverse events.
Measured: Up to 3 years
Baseline statin use
The analysis of the interaction of statin use and the 3-year event rate will be performed using logistic regression.
Measured: Up to 3 years
Baseline meat consumption
The analysis of the interaction of meat consumption and the 3-year event rate will be performed using logistic regression.
Measured: Up to 3 years
PK analysis
SNPs with minor allele frequencies greater than 0.20 will be selected for SNP genotyping. The smallest set of SNPs that tag the common variation (frequency > 0.20) in all of the representative ethnic groups will be used. The genotype data, treatment characteristics and endpoints of interest will be analyzed using the pharmacogenetic-environment interaction approach described by Wacholder and colleagues.
Measured: Up to 3 years
Biomarker identification based on Integrated Comprehensive Droplet Digital Detection technology
The nature of the relationship between biomarker values identified by Integrated Comprehensive Droplet Digital Detection technology and the aggregate primary endpoint (high-risk adenoma or second primary CRC) will be assessed. Statistical assessments of association between the biomarker and the recurrence endpoints will be performed after converting the biomarker scores to ranks, which will facilitate detection of monotonic relationship(s).
Measured: Up to 3 years (though the timing of this isn't clear to me)
Cancer type (colorectal vs rectal)
The analysis of the interaction of cancer type (colorectal vs rectal) and the 3-year event rate will be performed using logistic regression.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start23 Aug 2013
- Primary completion15 Sep 2027 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Jason A. Zell, D.O., MPH, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349881
- Sponsor's protocol ID
- S0820
- Other IDs
- U10CA037429, NCI-2012-02067
- Acronym
- PACES
- Status last verified
- Apr 2026
- First submitted
- 5 May 2011
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes