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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 Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
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
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
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
Foote Hospital Jackson, Michigan  49201
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
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
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
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
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
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
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
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital 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
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Wesley Medical Center Wichita, Kansas  67214
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC 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
Community Medical Center Missoula, Montana  59801
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
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
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Valley Cancer Center Spring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
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
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
Alexandria, Minnesota  56308
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
LaFortune Cancer Center at St. John Medical Center Tulsa, Oklahoma  74104
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
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
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Flower Hospital Cancer Center Sylvania, Ohio  43560
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
AnMed Cancer Center Anderson, South Carolina  29621
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Immanuel St. Joseph's Mankato, Minnesota  56002