Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

June 26, 2024

Primary Completion Date

January 30, 2030

Study Completion Date

June 30, 2030

Conditions
Rectal Cancer
Interventions
DRUG

Leucovorin

400 mg/m2

DRUG

Oxaliplatin

85 mg/m2 or 130 mg/m2 on day 1

DRUG

Fluoruracil

bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2

DRUG

Capecitabine

1,000 mg/m2 twice daily for 14 days

RADIATION

Radiation

54 Gy (27-30 fractions)

Trial Locations (79)

19317

RECRUITING

Christiana Care Health System-Concord Health Center, Chadds Ford

19713

RECRUITING

Helen F Graham Cancer Center, Newark

RECRUITING

Medical Oncology Hematology Consultants PA, Newark

19967

RECRUITING

Beebe South Coastal Health Campus, Millville

19971

RECRUITING

Beebe Health Campus, Rehoboth Beach

27834

RECRUITING

East Carolina University, Greenville

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

RECRUITING

Emory Saint Joseph's Hospital, Atlanta

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

38138

RECRUITING

The West Clinic - Wolf River, Germantown

45069

RECRUITING

University of Cincinnati Cancer Center-West Chester, West Chester

45219

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

45331

RECRUITING

Miami Valley Cancer Care and Infusion, Greenville

45373

RECRUITING

Upper Valley Medical Center, Troy

45409

SUSPENDED

Miami Valley Hospital, Dayton

RECRUITING

Premier Blood and Cancer Center, Dayton

45415

RECRUITING

Miami Valley Hospital North, Dayton

45459

RECRUITING

Miami Valley Hospital South, Centerville

46307

RECRUITING

Northwest Cancer Center - Main Campus, Crown Point

46311

RECRUITING

Northwest Oncology LLC, Dyer

46321

RECRUITING

The Community Hospital, Munster

46342

RECRUITING

Northwest Cancer Center - Hobart, Hobart

RECRUITING

Saint Mary Medical Center, Hobart

46383

RECRUITING

Northwest Cancer Center - Valparaiso, Valparaiso

48038

RECRUITING

Henry Ford Macomb Hospital-Clinton Township, Clinton Township

48202

RECRUITING

Henry Ford Hospital, Detroit

48322

RECRUITING

Henry Ford West Bloomfield Hospital, West Bloomfield

48377

RECRUITING

Henry Ford Medical Center-Columbus, Novi

49007

RECRUITING

West Michigan Cancer Center, Kalamazoo

49201

RECRUITING

Allegiance Health, Jackson

49503

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

54449

RECRUITING

Marshfield Medical Center-Marshfield, Marshfield

54476

RECRUITING

Marshfield Medical Center - Weston, Weston

54482

RECRUITING

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54548

RECRUITING

Marshfield Medical Center - Minocqua, Minocqua

54701

RECRUITING

Marshfield Medical Center-EC Cancer Center, Eau Claire

54868

RECRUITING

Marshfield Medical Center-Rice Lake, Rice Lake

56601

RECRUITING

Sanford Joe Lueken Cancer Center, Bemidji

57104

RECRUITING

Sanford Cancer Center Oncology Clinic, Sioux Falls

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

RECRUITING

Sanford Roger Maris Cancer Center, Fargo

58501

RECRUITING

Sanford Bismarck Medical Center, Bismarck

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

RECRUITING

Northwestern University, Chicago

61801

RECRUITING

Carle Cancer Center, Urbana

61832

RECRUITING

Carle at The Riverfront, Danville

61938

RECRUITING

Carle Physician Group-Mattoon/Charleston, Mattoon

62401

RECRUITING

Carle Physician Group-Effingham, Effingham

70112

RECRUITING

University Medical Center New Orleans, New Orleans

85004

RECRUITING

Cancer Center at Saint Joseph's, Phoenix

87106

RECRUITING

University of New Mexico Cancer Center, Albuquerque

89502

RECRUITING

Renown Regional Medical Center, Reno

92612

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine

92868

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

97015

RECRUITING

Clackamas Radiation Oncology Center, Clackamas

97030

RECRUITING

Legacy Mount Hood Medical Center, Gresham

97045

RECRUITING

Providence Willamette Falls Medical Center, Oregon City

97062

RECRUITING

Legacy Meridian Park Hospital, Tualatin

97132

RECRUITING

Providence Newberg Medical Center, Newberg

97210

RECRUITING

Legacy Good Samaritan Hospital and Medical Center, Portland

97213

RECRUITING

Providence Portland Medical Center, Portland

97225

RECRUITING

Providence Saint Vincent Medical Center, Portland

97239

RECRUITING

Oregon Health and Science University, Portland

98101

RECRUITING

Virginia Mason Medical Center, Seattle

98684

RECRUITING

Legacy Cancer Institute Medical Oncology and Day Treatment, Vancouver

98686

RECRUITING

Legacy Salmon Creek Hospital, Vancouver

01805

RECRUITING

Lahey Hospital and Medical Center, Burlington

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

45005-1066

RECRUITING

Atrium Medical Center-Middletown Regional Hospital, Franklin

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05819

RECRUITING

Dartmouth Cancer Center - North, Saint Johnsbury

R3E 0V9

RECRUITING

CancerCare Manitoba, Winnipeg

K1H 8L6

RECRUITING

Ottawa Hospital and Cancer Center-General Campus, Ottawa

H1T 2M4

RECRUITING

CIUSSSEMTL-Hopital Maisonneuve-Rosemont, Montreal

S4T 7T1

SUSPENDED

Allan Blair Cancer Centre, Regina

S7N 4H4

SUSPENDED

Saskatoon Cancer Centre, Saskatoon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alliance for Clinical Trials in Oncology

OTHER

collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

collaborator

NRG Oncology

OTHER

collaborator

SWOG Cancer Research Network

NETWORK

lead

Canadian Cancer Trials Group

NETWORK