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Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Dermatologic Complications, Radiation Toxicity, Skin Reactions Secondary to Radiation Therapy

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Trial Information

Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy


OBJECTIVES:

Primary

- Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal
severity of radiation dermatitis, in patients undergoing primary or adjuvant
radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma
in situ.

Secondary

- Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated
with these drugs.

- Compare the time to onset and duration of severe radiation dermatitis in these
patients.

- Assess skin toxicity and quality of life of these patients.

- Assess the adverse event profile of mometasone furoate in these patients.

- Compare skin toxicity data, in terms of provider-completed and patient-reported
assessments, of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to radiation field (breast [post-lumpectomy] vs chest wall
[post-mastectomy]), regional lymph nodes (treated vs not treated), and planned total
radiation dose (including boost) (50-55 Gy vs > 55 Gy). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast
or chest wall) for the duration of planned radiotherapy.

- Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in
arm I.

Patients complete questionnaires and a symptom experience diary at baseline and periodically
during study for quality of life, skin toxicity, and adverse event assessment.

After completion of radiotherapy, patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of primary invasive breast cancer or ductal
carcinoma in situ

- Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam
radiotherapy to 1 of the following sites:

- Whole breast (as part of breast-conservation therapy)

- Chest wall (as part of post-mastectomy irradiation)

- Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or
internal mammary) allowed

- Must meet the following criteria for planned radiotherapy:

- Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75
and 2.12 Gy

- No planned split-course radiotherapy

- No partial breast treatment, defined as treatment of < 75% of the breast
parenchyma

- Intensity-modulated radiotherapy planning and delivery, conventional
radiotherapy, or 3-dimensional radiotherapy techniques allowed

- Must be entered on study within 7 days prior to beginning radiotherapy

- Must start study drug prior to receiving the third radiotherapy fraction

- No preexisting skin breakdown within the planned radiotherapy field at the time of
study entry

- No bilateral breast cancer treatment

- No inflammatory carcinoma of the breast

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Male or female

- Menopausal status not specified

- ECOG performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to complete questionnaires independently or with assistance

- No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic
cream), imidazolidinyl urea, or formaldehyde

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radiotherapy to the planned radiotherapy treatment area

- No concurrent or planned leukotriene inhibitors, including the following:

- Zafirleukast

- Monteleukast

- Zileuton

- No concurrent or planned use of any prescription or over-the-counter medications
containing hydrocortisone or any other cortisone or steroid-containing preparations
(systemic, local, or topical) including, but not limited to, the following creams or
ointments:

- Cortaid®

- Cortizone 10®

- Tucks®

- Preparation H®

- No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field
during study treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0

Safety Issue:

Yes

Principal Investigator

Robert C. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000530309

NCT ID:

NCT00438659

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Dermatologic Complications
  • Radiation Toxicity
  • Skin Reactions Secondary to Radiation Therapy
  • dermatologic complications
  • skin reactions secondary to radiation therapy
  • radiation toxicity
  • breast cancer in situ
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • male breast cancer
  • ductal breast carcinoma in situ
  • stage IV breast cancer
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Dermatitis
  • Radiodermatitis
  • Radiation Injuries

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
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
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
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
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
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
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Wesley Medical CenterWichita, Kansas  67214
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Mount Carmel Health - West HospitalColumbus, Ohio  43222
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Alexandria, Minnesota  56308
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
LaFortune Cancer Center at St. John Medical CenterTulsa, Oklahoma  74104
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Cancer Resource Center - LincolnLincoln, Nebraska  68510
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
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
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Flower Hospital Cancer CenterSylvania, Ohio  43560
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Galesburg Clinic, PCGalesburg, Illinois  61401
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
AnMed Cancer CenterAnderson, South Carolina  29621
Franciscan Skemp Healthcare - La Crosse CampusLa Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Immanuel St. Joseph'sMankato, Minnesota  56002