Trial record 1 of 179 for:    N08C9
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Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01198145
First received: September 8, 2010
Last updated: August 6, 2013
Last verified: February 2013
  Purpose

RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.


Condition Intervention Phase
Diarrhea
Gastrointestinal Complications
Unspecified Adult Solid Tumor, Protocol Specific
Drug: sulfasalazine
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Maximum severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after radiotherapy (RT) [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum severity and the duration of maximum severity of each outcome variable (i.e., rectal bleeding, abdominal cramping, tenesmus, constipation, and diarrhea) measured during and after RT [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: Yes ]
  • Area under the curve that combines the individual severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after RT [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: Yes ]
  • Average score for each outcome variable [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: No ]
  • Percentage of patients in each arm that experience each outcome variable during and after RT [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: No ]
  • Long-term diarrhea severity grade [ Time Frame: Up to 24 months post radiation therapy ] [ Designated as safety issue: No ]
  • Long-term bowel function score [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Percent of patients in each arm that recorded "yes" to each of questions 2-12 on the bowel function questionnaire [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Percentage of patients in each arm that require any and each type of antidiarrheal medications [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Percentage of patients in each arm that experience clinically significant deficits in overall quality of life and fatigue [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: April 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral sulfasalazine twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Drug: sulfasalazine
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy.

Secondary

  • To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy.
  • To determine whether sulfasalazine causes any toxicity in this situation.

Tertiary

  • To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational)

OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs > 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.
  • Arm II: Patients receive oral placebo twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.

NOTE: *Patients must start study treatment by the third radiotherapy fraction.

Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy.

After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer that supports the use of radiotherapy to the pelvis
  • No current or prior metastases beyond pelvic regional lymph nodes
  • Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin
  • Planned course of pelvic radiotherapy must fall within the following parameters:

    • Pelvis must be encompassed by the planned radiotherapy fields

      • Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
      • Portions of the rectum may have special blocking, depending upon disease site
    • Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)*

      • Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned
    • Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

      • Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day*
  • NOTE: *For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
  • No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
  • No brachytherapy planned before the completion of all external-beam radiotherapy
  • No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Hemoglobin ≥ 10.0 g/dL
  • Leukocytes ≥ 3,500/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
  • Able to complete questionnaires alone or with assistance
  • No history of inflammatory bowel disease
  • No history of gastrointestinal or genitourinary obstruction or porphyria
  • No history of G6PD deficiency
  • No history of irritable bowel syndrome
  • No history of blood dyscrasia
  • No history of severe allergies or asthma
  • No history of hepatic or renal disease
  • No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
  • No medical condition that may interfere with the ability to receive study treatment
  • No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
  • No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
  • No other concurrent sulfasalazine
  • No concurrent digoxin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198145

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Locations
United States, Arizona
Mayo Clinic Hospital
Phoeniz, Arizona, United States, 85054
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Rose Medical Center
Denver, Colorado, United States, 80220
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States, 96813
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817
Hawaii Medical Center - East
Honolulu, Hawaii, United States, 96817
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
St. Francis Hospital Cancer Care Services
Indianapolis, Indiana, United States, 46237
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Iowa
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Mercy Cancer Center - West Lakes
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Essentia Health - Duluth Clinic
Duluth, Minnesota, United States, 55805-1983
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Central Care Cancer Center at Carrie J. Babb Cancer Center
Bolivar, Missouri, United States, 65613
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Lakeside Hospital
Omaha, Nebraska, United States, 68130
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, United States, 88011
United States, New York
Mount Kisco Medical Group, PC
Mount Kisco, New York, United States, 10549-3417
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203-5400
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28053
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Park Ridge Hospital
Hendersonville, North Carolina, United States, 28792
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, North Dakota
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
MeritCare Broadway
Fargo, North Dakota, United States, 58102
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
CCOP - Dayton
Dayton, Ohio, United States, 45420
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37662
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States, 24115
United States, Washington
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States, 98686
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond du Lac, Wisconsin, United States, 54935
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
St. Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, United States, 54481
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States, 54235-1495
Ministry Saint Clare's Hospital
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Robert C. Miller, MD Mayo Clinic
Study Chair: Daniel A. Petereit, MD Rapid City Regional Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01198145     History of Changes
Other Study ID Numbers: NCCTG-N08C9, NCI-2011-02602, CDR0000684240
Study First Received: September 8, 2010
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
diarrhea
gastrointestinal complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Sulfasalazine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014