Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ
This study has been completed.
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00438659
First received: February 20, 2007
Last updated: September 20, 2011
Last verified: January 2009
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Purpose
RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.
PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Dermatologic Complications Radiation Toxicity Skin Reactions Secondary to Radiation Therapy |
Drug: mometasone furoate Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of severe (grade ≥ 3) radiation dermatitis [ Designated as safety issue: Yes ]
- Time to onset of severe radiation dermatitis [ Designated as safety issue: Yes ]
- Duration of severe radiation dermatitis [ Designated as safety issue: Yes ]
- Overall quality of life (QOL) as measured by Linear Analogue Self-Assessment (LASA) [ Designated as safety issue: No ]
- QOL domains as measured by LASA [ Designated as safety issue: No ]
- Skin toxicity as measured by Skindex-16 [ Designated as safety issue: Yes ]
- Skin toxicity as measured by the Skin Toxicity Assessment Tool [ Designated as safety issue: Yes ]
- Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and assessed clinically by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 148 |
| Study Start Date: | August 2007 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
|
Drug: mometasone furoate
Applied to treatment area
|
|
Placebo Comparator: Arm II
Patients apply an identical-appearing placebo cream to the treatment area as in arm I.
|
Other: placebo
Applied to treatment area
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438659
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| United States, Illinois | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| InterCommunity Cancer Center of Western Illinois | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Clinic, PC | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | |
| Moline, Illinois, United States, 61265 | |
| Moline, Illinois, United States, 61265 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61615-7827 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| Valley Cancer Center | |
| Spring Valley, Illinois, United States, 61362 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| McFarland Clinic, PC | |
| Ames, Iowa, United States, 50010 | |
| Bettendorf, Iowa, United States, 52722 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| 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 | |
| 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 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | |
| Mason City, Iowa, United States, 50401 | |
| McCreery Cancer Center at Ottumwa Regional | |
| Ottumwa, Iowa, United States, 52501 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| 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, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Southwest Medical Center | |
| 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, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| 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 Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | |
| Lambertville, Michigan, United States, 48144 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48912-1811 | |
| Mercy Memorial Hospital - Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| United States, Minnesota | |
| Alexandria, Minnesota, United States, 56308 | |
| MeritCare Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| 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 | |
| Duluth Clinic Cancer Center - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Meeker County Memorial Hospital | |
| Lichfield, Minnesota, United States, 55355 | |
| Immanuel St. Joseph's | |
| Mankato, Minnesota, United States, 56002 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| Minnesota Oncology Hematology, PA - Maplewood | |
| 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 | |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| St. Francis Cancer Center at St. Francis Medical Center | |
| Shakopee, Minnesota, United States, 55379 | |
| HealthEast Cancer Care at St. Joseph's Hospital | |
| St Paul, Minnesota, United States, 55102 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Park Nicollet Cancer Center | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| HealthEast Cancer Care at Woodwinds Health Campus | |
| Woodbury, Minnesota, United States, 55125 | |
| United States, Missouri | |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | |
| Saint Louis, Missouri, United States, 63141 | |
| Missouri Baptist Cancer Center | |
| St. Louis, Missouri, United States, 63131 | |
| United States, Montana | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| St. Vincent Healthcare Cancer Care Services | |
| Billings, Montana, United States, 59101 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Bozeman Deaconess Cancer Center | |
| Bozeman, Montana, United States, 59715 | |
| St. James Healthcare Cancer Care | |
| Butte, Montana, United States, 59701 | |
| Great Falls Clinic - Main Facility | |
| Great Falls, Montana, United States, 59405 | |
| Great Falls, Montana, United States, 59405 | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405-5309 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Kalispell Medical Oncology at KRMC | |
| Kalispell, Montana, United States, 59901 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| 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 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Guardian Oncology and Center for Wellness | |
| Missoula, Montana, United States, 59804 | |
| 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 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center Cancer Center | |
| Bismarck, North Dakota, United States, 58502 | |
| Medcenter One Hospital Cancer Care Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Mid Dakota Clinic, PC | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Mary Rutan Hospital | |
| Bellefontaine, Ohio, United States, 43311 | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Grant Medical Center Cancer Care | |
| Columbus, Ohio, United States, 43215 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Fremont Memorial Hospital | |
| Fremont, Ohio, United States, 43420 | |
| 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 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537 | |
| 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 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| North Coast Cancer Care, Incorporated | |
| Sandusky, Ohio, United States, 44870 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43617 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Mount Carmel St. Ann's Cancer Center | |
| Westerville, Ohio, United States, 43081 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| LaFortune Cancer Center at St. John Medical Center | |
| Tulsa, Oklahoma, United States, 74104 | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| 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 | |
| Medical X-Ray Center, PC | |
| 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, Virginia | |
| Fredericksburg Oncology, Incorporated | |
| Fredericksburg, Virginia, United States, 22401 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Franciscan Skemp Healthcare - La Crosse Campus | |
| La Crosse, Wisconsin, United States, 54601 | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Robert C. Miller, MD | Mayo Clinic |
| Investigator: | Patricia Griffin, MD | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center |
| Investigator: | James A. Martenson, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| Responsible Party: | Charles L. Loprinzi, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00438659 History of Changes |
| Other Study ID Numbers: | CDR0000530309, NCCTG-N06C4 |
| Study First Received: | February 20, 2007 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Dermatitis Radiodermatitis Radiation Injuries Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Wounds and Injuries Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013