FORTE: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

• Sponsor: NRG Oncology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05080673
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 9,500
• Locations: 165
• Arms: 2
• Anticipated Duration (Months): 528.9
• Patients Per Site: 57.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum	Procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy	N/A

Detailed Description

Colorectal cancer (CRC) is the fourth most common cancer and the second leading cause of cancer death among men and women in the United States (US). The lifetime risk of colorectal cancer in both men and women in the US is approximately 6%. About 93% of colorectal cancer (CRC) diagnoses are in patients older than 50 years (Siegel 2014). Randomized controlled trials show that screening for CRC significantly decreases CRC incidence and mortality (Schoen 2012, Atkin 2010, Mandel 1999, Mandel 2000). CRC screening has received a Grade A recommendation from the US Preventive Services Task Force.

In the U.S., colonoscopy is the most utilized screening modality for CRC. On a population basis, screening rates, which were around 40-50%, have now increased to 65%, and a goal to increase to 80% compliance is being promoted (CDC 2011, CDC 2013, Meester 2015).

Adenomatous polyps are the acknowledged precursors of colorectal cancer. Identification and removal of adenomas is the mechanism by which screening is effective in reducing CRC incidence and subsequent mortality. "Advanced" adenomas are adenomas which are greater than or equal to 1 cm, or have a "villous" component (tubulovillous or villous), or have foci of high grade dysplasia. Advanced adenomas are associated with increased long-term risk of cancer, even years after colonoscopy (Click 2018). The prevalence of advanced adenomas at screening colonoscopy is 5-10% (Ferlitsch 2011, Imperiale 2014). Non-advanced adenomas are adenomas greater than 1 cm with neither villous components nor high grade dysplasia. Non-advanced adenomas are much more common than advanced adenomas, present in around 30% of colonoscopy exams (Ferlitsch 2011, Imperiale 2014).

After detection of adenomas, patients are advised to return periodically for surveillance colonoscopy. Patients with 1-2 non-advanced adenomas are recommended by guidelines to return in 5 - 10 years for follow-up surveillance colonoscopy (Lieberman 2012). However, there are no guidelines on how to triage individuals to 5 as opposed to 10 years. Furthermore, there is limited evidence supporting the effectiveness of surveillance colonoscopy in reducing CRC incidence. A retrospective study in patients with advanced adenomas demonstrated benefit (Atkin 2017), but the study was not randomized and did not include patients with 1-2 non-advanced adenomas. The only randomized trial of surveillance colonoscopy was reported in the early 1990's, when participants were randomized to 3 vs. 1- and 3- year surveillance (Winawer 1993). No difference in advanced adenoma detection was observed when comparing participants examined at the two screening intervals, and as a result, guidelines were modified with participants advised to return every 3 years after adenomatous polyp detection. The recommended interval for non-advanced adenomas was gradually lengthened to the current standard, but there is no randomized, controlled data to support that interval. Furthermore, observational data of surveillance colonoscopy practice in the U.S. demonstrate that recommended intervals are often not adhered to, and individuals return for repeat testing well ahead of guideline recommendations (Schoen 2010, Lieberman 2014).

Furthermore, if anything, retrospective, natural history studies of non-advanced adenomas do not support the association of non-advanced adenoma with a higher risk of subsequent colorectal cancer (Atkin 1992, Spencer 1984, Loberg 2014). For example, in a classic study from the United Kingdom, patients with small rectosigmoid adenomas, even if multiple, did not have an increased risk of CRC compared to the general population, over a 14-year mean follow-up time (Atkin 1992). In a recent observational study from Norway, participants with a low-risk adenoma followed over a median of 7.7 years (maximum 19 years) without subsequent surveillance colonoscopy, had a lower CRC mortality than the general population (Loberg 2014), implying that although the initial colonoscopy may be protective, subsequent follow-up colonoscopy was not required. More recently, several studies have reported that individuals with non-advanced adenomas do not have an increased risk of colorectal cancer compared to those with no adenomas (Click 2018, Lieberman 2019, Lee 2019).

Another recent major development affecting screening is that practitioners of colonoscopy are now recommended to monitor and insure their adenoma detection rates are high. Data from Poland (Kaminski 2010) and Kaiser Permanente in California (Corley 2014) have demonstrated that a higher adenoma detection rate (ADR) is associated with a lower long-term risk of interval CRC, or cancer occurring after colonoscopy. Our understanding of these observations is premised on the notion that leaving pre-neoplastic tissue (adenomas) in situ, (such as what occurs with a lower ADR), increases the chance that an adenoma left behind will subsequently transform into cancer. The concern over interval cancers has stimulated quality concerns about the practice of colonoscopy. Guidelines for a recommended ADR at screening colonoscopy are rising, from the initial targets of 15% in women and 25% in men (Lieberman 2012) to 20% in women and 30% in men or 25% overall. ADRs in clinical studies are now commonly over 30% and some practitioners report rates exceeding 50%. However, adenomas that are detected when the ADR is high or as it increases over time are generally small, non-advanced adenomas.

Current clinical practice favoring colonoscopy-based screening with increased emphasis on detection of adenomas, most of which will turn out to be small, non-advanced adenomas, will greatly increase demand for utilization of surveillance colonoscopy exams in the coming decades. Yet, the evidence for determining the benefit, optimal timing, and recommended frequency of surveillance colonoscopy is unknown. A randomized, clinical trial to demonstrate the difference in yield between 5- or 10-year surveillance for participants with non-advanced adenoma is needed to guide clinical practice. Only a randomized trial will be authoritative enough to define good clinical practice and directly influence clinical care.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 9500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: SurveillanceSurveillance
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
• Actual Study Start Date: Oct 6, 2021
• Anticipated Primary Completion Date: Nov 1, 2035
• Anticipated Study Completion Date: Nov 1, 2065

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 5-Year and 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy	Procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy; The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.
Experimental: Arm 2 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy	Procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy; The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.

Outcome Measures

Primary Outcome Measures

1. Incidence of colorectal cancer [10 years]

   To examine colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Other Outcome Measures

1. Incidence of advanced adenoma [10 years]

   To examine advanced adenoma incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

2. Colorectal cancer mortality [10 years]

   To examine colorectal cancer mortality in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

3. Incidence of stage III-IV colorectal cancer [10 years]

   To examine stage III-IV colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• • The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.

• Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization.

• Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.

• Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.

• Complete excision of all observed polyps in qualifying colonoscopy

• Participants must be able to read or understand English or Spanish.

Exclusion Criteria:

• • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy.

• Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.

• Traditional serrated adenomas found on the qualifying colonoscopy.

• Hyperplastic polyp measuring less than or equal to 1 cm in size found on the qualifying colonoscopy.

• Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.

• Colonoscopy performed after the qualifying colonoscopy but prior to randomization.

• Incomplete qualifying colonoscopy (e.g., cecum not visualized).

• Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)

• Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)

• Family history of CRC diagnosed at greater than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.

• Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome]).

• Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome] genetic mutation that increases risk of colorectal cancer.

• Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).

• Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.

• Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center at Saint Joseph's	Phoenix	Arizona	United States	85004
2	CHI Saint Vincent Cancer Center Hot Springs	Hot Springs	Arkansas	United States	71913
3	Mission Hope Medical Oncology - Arroyo Grande	Arroyo Grande	California	United States	93420
4	Epic Care-Dublin	Dublin	California	United States	94568
5	Bay Area Breast Surgeons Inc	Emeryville	California	United States	94608
6	Epic Care Partners in Cancer Care	Emeryville	California	United States	94608
7	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California	United States	90095
8	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
9	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
10	Bay Area Tumor Institute	Oakland	California	United States	94609
11	Pacific Central Coast Health Center-San Luis Obispo	San Luis Obispo	California	United States	93401
12	Mission Hope Medical Oncology - Santa Maria	Santa Maria	California	United States	93444
13	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
14	Epic Care Cyberknife Center	Walnut Creek	California	United States	94597
15	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado	United States	80907
16	Rocky Mountain Cancer Centers-Penrose	Colorado Springs	Colorado	United States	80907
17	Saint Francis Cancer Center	Colorado Springs	Colorado	United States	80923
18	Porter Adventist Hospital	Denver	Colorado	United States	80210
19	Mercy Medical Center	Durango	Colorado	United States	81301
20	Southwest Oncology PC	Durango	Colorado	United States	81301
21	Saint Anthony Hospital	Lakewood	Colorado	United States	80228
22	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
23	Longmont United Hospital	Longmont	Colorado	United States	80501
24	Rocky Mountain Cancer Centers-Longmont	Longmont	Colorado	United States	80501
25	Parker Adventist Hospital	Parker	Colorado	United States	80138
26	Saint Mary Corwin Medical Center	Pueblo	Colorado	United States	81004
27	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
28	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
29	Rush University Medical Center	Chicago	Illinois	United States	60612
30	Carle on Vermilion	Danville	Illinois	United States	61832
31	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
32	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
33	Carle Cancer Center	Urbana	Illinois	United States	61801
34	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
35	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
36	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
37	Mercy Cancer Center-West Lakes	Clive	Iowa	United States	50325
38	Alegent Health Mercy Hospital	Council Bluffs	Iowa	United States	51503
39	Greater Regional Medical Center	Creston	Iowa	United States	50801
40	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
41	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
42	Mercy Medical Center-West Lakes	West Des Moines	Iowa	United States	50266
43	Flaget Memorial Hospital	Bardstown	Kentucky	United States	40004
44	Commonwealth Cancer Center-Corbin	Corbin	Kentucky	United States	40701
45	Saint Joseph Radiation Oncology Resource Center	Lexington	Kentucky	United States	40504
46	Saint Joseph Hospital East	Lexington	Kentucky	United States	40509
47	Saint Joseph London	London	Kentucky	United States	40741
48	Jewish Hospital	Louisville	Kentucky	United States	40202
49	Saints Mary and Elizabeth Hospital	Louisville	Kentucky	United States	40215
50	UofL Health Medical Center Northeast	Louisville	Kentucky	United States	40245
51	Jewish Hospital Medical Center South	Shepherdsville	Kentucky	United States	40165
52	Bronson Battle Creek	Battle Creek	Michigan	United States	49017
53	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
54	Mercy Health Saint Mary's	Grand Rapids	Michigan	United States	49503
55	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
56	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
57	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
58	Ascension Borgess Cancer Center	Kalamazoo	Michigan	United States	49009
59	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
60	Mercy Health Mercy Campus	Muskegon	Michigan	United States	49444
61	Lakeland Hospital Niles	Niles	Michigan	United States	49120
62	Cancer and Hematology Centers of Western Michigan - Norton Shores	Norton Shores	Michigan	United States	49444
63	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
64	Lakeland Medical Center Saint Joseph	Saint Joseph	Michigan	United States	49085
65	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
66	Munson Medical Center	Traverse City	Michigan	United States	49684
67	Metro Health Hospital	Wyoming	Michigan	United States	49519
68	Riverwood Healthcare Center	Aitkin	Minnesota	United States	56431
69	Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	United States	56601
70	Essentia Health Saint Joseph's Medical Center	Brainerd	Minnesota	United States	56401
71	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
72	Minnesota Oncology - Burnsville	Burnsville	Minnesota	United States	55337
73	Cambridge Medical Center	Cambridge	Minnesota	United States	55008
74	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
75	Essentia Health - Deer River Clinic	Deer River	Minnesota	United States	56636
76	Essentia Health Saint Mary's - Detroit Lakes Clinic	Detroit Lakes	Minnesota	United States	56501
77	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
78	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
79	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
80	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
81	Lake Region Healthcare Corporation-Cancer Care	Fergus Falls	Minnesota	United States	56537
82	Essentia Health - Fosston	Fosston	Minnesota	United States	56542
83	Unity Hospital	Fridley	Minnesota	United States	55432
84	Essentia Health Hibbing Clinic	Hibbing	Minnesota	United States	55746
85	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota	United States	55369
86	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
87	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
88	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
89	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
90	Health Partners Inc	Minneapolis	Minnesota	United States	55454
91	Monticello Cancer Center	Monticello	Minnesota	United States	55362
92	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
93	Essentia Health - Park Rapids	Park Rapids	Minnesota	United States	56470
94	Fairview Northland Medical Center	Princeton	Minnesota	United States	55371
95	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
96	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
97	Regions Hospital	Saint Paul	Minnesota	United States	55101
98	United Hospital	Saint Paul	Minnesota	United States	55102
99	Essentia Health Sandstone	Sandstone	Minnesota	United States	55072
100	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
101	Lakeview Hospital	Stillwater	Minnesota	United States	55082
102	Sanford Thief River Falls Medical Center	Thief River Falls	Minnesota	United States	56701
103	Essentia Health Virginia Clinic	Virginia	Minnesota	United States	55792
104	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
105	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
106	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
107	Sanford Cancer Center Worthington	Worthington	Minnesota	United States	56187
108	Fairview Lakes Medical Center	Wyoming	Minnesota	United States	55092
109	CHI Health Saint Francis	Grand Island	Nebraska	United States	68803
110	CHI Health Good Samaritan	Kearney	Nebraska	United States	68847
111	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
112	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
113	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
114	Alegent Health Lakeside Hospital	Omaha	Nebraska	United States	68130
115	Creighton University Medical Center	Omaha	Nebraska	United States	68131
116	Midlands Community Hospital	Papillion	Nebraska	United States	68046
117	Morristown Medical Center	Morristown	New Jersey	United States	07960
118	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
119	Essentia Health Cancer Center-South University Clinic	Fargo	North Dakota	United States	58103
120	Sanford South University Medical Center	Fargo	North Dakota	United States	58103
121	Southpointe-Sanford Medical Center Fargo	Fargo	North Dakota	United States	58103
122	Sanford Medical Center Fargo	Fargo	North Dakota	United States	58104
123	Sanford Broadway Medical Center	Fargo	North Dakota	United States	58122
124	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
125	Essentia Health - Jamestown Clinic	Jamestown	North Dakota	United States	58401
126	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio	United States	45220
127	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
128	TriHealth Cancer Institute-Westside	Cincinnati	Ohio	United States	45247
129	TriHealth Cancer Institute-Anderson	Cincinnati	Ohio	United States	45255
130	UPMC-Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
131	Ralph H Johnson VA Medical Center	Charleston	South Carolina	United States	29401
132	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
133	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota	United States	57104
134	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
135	Saint Joseph Regional Cancer Center	Bryan	Texas	United States	77802
136	Harrison Medical Center	Bremerton	Washington	United States	98310
137	Highline Medical Center-Main Campus	Burien	Washington	United States	98166
138	Saint Elizabeth Hospital	Enumclaw	Washington	United States	98022
139	Saint Francis Hospital	Federal Way	Washington	United States	98003
140	Saint Clare Hospital	Lakewood	Washington	United States	98499
141	Franciscan Research Center-Northwest Medical Plaza	Tacoma	Washington	United States	98405
142	Ascension Saint Elizabeth Hospital	Appleton	Wisconsin	United States	54915
143	Duluth Clinic Ashland	Ashland	Wisconsin	United States	54806
144	Northwest Wisconsin Cancer Center	Ashland	Wisconsin	United States	54806
145	Ascension Southeast Wisconsin Hospital - Elmbrook Campus	Brookfield	Wisconsin	United States	53045
146	Ascension Calumet Hospital	Chilton	Wisconsin	United States	53014
147	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
148	Ascension Saint Francis - Reiman Cancer Center	Franklin	Wisconsin	United States	53132
149	Ascension Southeast Wisconsin Hospital - Franklin	Franklin	Wisconsin	United States	53132
150	Essentia Health-Hayward Clinic	Hayward	Wisconsin	United States	54843
151	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
152	Ascension Columbia Saint Mary's Hospital Ozaukee	Mequon	Wisconsin	United States	53097
153	Ascension Southeast Wisconsin Hospital - Saint Joseph Campus	Milwaukee	Wisconsin	United States	53210
154	Ascension Columbia Saint Mary's Hospital - Milwaukee	Milwaukee	Wisconsin	United States	53211
155	Ascension Saint Francis Hospital	Milwaukee	Wisconsin	United States	53215
156	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
157	Cancer Center of Western Wisconsin	New Richmond	Wisconsin	United States	54017
158	Ascension Mercy Hospital	Oshkosh	Wisconsin	United States	54904
159	Ascension All Saints Hospital	Racine	Wisconsin	United States	53405
160	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin	United States	54868
161	Essentia Health-Spooner Clinic	Spooner	Wisconsin	United States	54801
162	Marshfield Clinic Stevens Point Center	Stevens Point	Wisconsin	United States	54482
163	Essentia Health Saint Mary's Hospital - Superior	Superior	Wisconsin	United States	54880
164	Ascension Medical Group Southeast Wisconsin - Mayfair Road	Wauwatosa	Wisconsin	United States	53226
165	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476

Sponsors and Collaborators

• NRG Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Robert Schoen, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NRG Oncology
• ClinicalTrials.gov Identifier: NCT05080673
• Other Study ID Numbers: NRG-CC005; NCI-2020-00733
• First Posted: Oct 18, 2021
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenocarcinoma; Adenomatous Polyps

Study Results

No Results Posted as of Apr 1, 2022