Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Maximum severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after radiotherapy (RT)
Yes
Robert C. Miller, MD
Study Chair
Mayo Clinic
Unspecified
CDR0000684240
NCT01198145
April 2011
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
MeritCare Broadway | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Hinsdale, Illinois 60521 | |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Bettendorf, Iowa 52722 | |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mayo Clinic Hospital | Phoenix, Arizona 85054-4502 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Community Cancer Center | Elyria, Ohio 44035 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Legacy Salmon Creek Medical Center | Vancouver, Washington 98686 |
Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
High Point Regional Hospital | High Point, North Carolina 27261 |
CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia, North Carolina 28053 |
Immanuel St. Joseph's | Mankato, Minnesota 56002 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
Central Wisconsin Cancer Program at Agnesian HealthCare | Fond du Lac, Wisconsin 54935 |
Southeast Cancer Center | Cape Girardeau, Missouri 63703 |
Goldschmidt Cancer Center | Jefferson City, Missouri 65109 |
Lakeside Hospital | Omaha, Nebraska 68130 |
University of New Mexico Cancer Center - South | Las Cruces, New Mexico 88011 |
St. Nicholas Hospital | Sheboygan, Wisconsin 53081 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |
Central Care Cancer Center at Carrie J. Babb Cancer Center | Bolivar, Missouri 65613 |
Mount Kisco Medical Group, PC | Mount Kisco, New York 10549 |
St. Francis Hospital Cancer Care Services | Indianapolis, Indiana 46237 |
Ministry Saint Clare's Hospital | Weston, Wisconsin 54476 |
Mercy Cancer Center - West Lakes | Clive, Iowa 50325 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Benefis Sletten Cancer Institute | Great Falls, Montana 59405 |
Essentia Health - Duluth Clinic | Duluth, Minnesota 55805-1983 |
Park Ridge Hospital | Hendersonville, North Carolina 28792 |