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Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Diarrhea, Gastrointestinal Complications, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Maximum severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after radiotherapy (RT)

Safety Issue:

Yes

Principal Investigator

Robert C. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

Unspecified

Study ID:

CDR0000684240

NCT ID:

NCT01198145

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Diarrhea
  • Gastrointestinal Complications
  • Unspecified Adult Solid Tumor, Protocol Specific
  • diarrhea
  • gastrointestinal complications
  • unspecified adult solid tumor, protocol specific
  • Diarrhea

Name

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Mayo Clinic ScottsdaleScottsdale, Arizona  85259
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Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
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CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
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Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
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Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
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Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
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Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
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HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
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Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
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Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
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St. Vincent Mercy Medical CenterToledo, Ohio  43608
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Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
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Toledo HospitalToledo, Ohio  43606
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Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
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Community Cancer Center of MonroeMonroe, Michigan  48162
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Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Iredell Memorial HospitalStatesville, North Carolina  28677
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Legacy Meridian Park HospitalTualatin, Oregon  97062
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
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Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
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Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
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Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
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Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Grant Medical Center Cancer CareColumbus, Ohio  43215
Hematology Oncology CenterElyria, Ohio  44035
Community Cancer CenterElyria, Ohio  44035
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Legacy Salmon Creek Medical CenterVancouver, Washington  98686
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
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Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Lakes Region General HospitalLaconia, New Hampshire  03246
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
Hawaii Medical Center - EastHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
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AnMed Cancer CenterAnderson, South Carolina  29621
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
High Point Regional HospitalHigh Point, North Carolina  27261
CaroMont Cancer Center at Gaston Memorial HospitalGastonia, North Carolina  28053
Immanuel St. Joseph'sMankato, Minnesota  56002
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
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Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Central Wisconsin Cancer Program at Agnesian HealthCareFond du Lac, Wisconsin  54935
Southeast Cancer CenterCape Girardeau, Missouri  63703
Goldschmidt Cancer CenterJefferson City, Missouri  65109
Lakeside HospitalOmaha, Nebraska  68130
University of New Mexico Cancer Center - SouthLas Cruces, New Mexico  88011
St. Nicholas HospitalSheboygan, Wisconsin  53081
Door County Cancer Center at Door County Memorial HospitalSturgeon Bay, Wisconsin  54235-1495
Central Care Cancer Center at Carrie J. Babb Cancer CenterBolivar, Missouri  65613
Mount Kisco Medical Group, PCMount Kisco, New York  10549
St. Francis Hospital Cancer Care ServicesIndianapolis, Indiana  46237
Ministry Saint Clare's HospitalWeston, Wisconsin  54476
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700
Benefis Sletten Cancer InstituteGreat Falls, Montana  59405
Essentia Health - Duluth ClinicDuluth, Minnesota  55805-1983
Park Ridge HospitalHendersonville, North Carolina  28792