AzTrials
AzTrials

Breast CancerPhase 1/2NCT00002873

Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer

A Phase 1/2 study testing brachytherapy in people with Breast Cancer, run by Radiation Therapy Oncology Group at 232 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Cancer
What is being tested?
brachytherapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
232 sitesin 2 countries
Study dates
May 1997to Jun 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed nonlobular invasive breast cancer of one of the following histologies: Ductal Papillary Medullary Colloid (mucinous) Tubular Stage I/II (T1-2 N0-1 M0) tumor no greater than 3 cm Prior tylectomy and axillary lymph node dissection required No more than 3 positive axillary lymph nodes and no extracapsular extension At least 6 lymph nodes sampled OR Negative sentinal node Surgical clips in place delineating margins of tylectomy cavity Negative, or close but negative, inked histologic margins of tylectomy or re-excision specimen Negative margins defined as no tumor at least 2 mm away from the inked margins Close but negative margins defined as tumor within 2 mm of inked margin Positive margins defined as invasive or noninvasive tumor at inked resection margins Negative post-tylectomy or post-reexcision mammogram required if disease presented with malignancy-associated microcalcifications No remaining suspicious microcalcifications If catheters are placed at time of reexcision, the crieria may not be feasible but a post brachytherapy mammogram should be obtained as soon as possible No extensive intraductal carcinoma by the Harvard definition, i.e.: More than 25% of tumor is ductal carcinoma in situ (DCIS) and there is DCIS in adjacent breast tissue OR Intraductal carcinoma with microinvasion No proven multicentric carcinoma, i.e.: Tumor in different quadrants of the breast OR Tumor separated by at least 4 cm The following exclude: Skin or chest wall invasion Matted or fixed axillary adenopathy Metastatic internal mammary or supraclavicular nodes Paget's disease of the nipple Previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No collagen vascular disease with a c-reactive protein level above normal or with an active skin rash (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) No coexisting medical condition that reduces life expectancy to less than 2 years No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for breast cancer Planned chemotherapy may begin at least 2 weeks after removal of brachytherapy catheters Endocrine therapy: Concurrent tamoxifen permitted Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics

Trial locations and contacts

232 sites in 2 countries.

232 sites in 2 countries

United States216 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44309

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Saint Joseph Medical Center

    Albuquerque, New Mexico, 87102

  • Providence Cancer Therapy Center

    Anchorage, Alaska, 99508

  • St. John's Medical Center

    Anderson, Indiana, 46016

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21225

  • Radiation Oncology Affiliates of Maryland, P.A.

    Baltimore, Maryland, 21237

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Julie and Ben Rogers Cancer Institute

    Beaumont, Texas, 77701

  • CCOP - Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Joint Center for Radiation Therapy

    Boston, Massachusetts, 02215

  • Medical Center at Bowling Green

    Bowling Green, Kentucky, 42102

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215-3609

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Lykes Center for Radiation Therapy

    Clearwater, Florida, 33757-0210

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Samaritan Regional Cancer Center

    Corvallis, Oregon, 97339

  • Penn State Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Mercy Catholic Medical Center, Mercy Fitzgerald Divison

    Darby, Pennsylvania, 19023

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Halifax Medical Center

    Daytona Beach, Florida, 32114

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Beckman Research Institute, City of Hope

    Duarte, California, 91010

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Elizabeth General Medical Center - West

    Elizabeth, New Jersey, 07201

  • Meritcare Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Radiation Therapy Associates - Fort Myers

    Fort Myers, Florida, 33901

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • University of Florida Health Science Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-1329

  • Glendale Memorial Hospital and Health Center

    Glendale, California, 91204

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Geisinger Cancer Center

    Hershey, Pennsylvania, 17033

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Huntsville Hospital System

    Huntsville, Alabama, 35801

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Clarion Health Partners Inc.

    Indianapolis, Indiana, 46206-1367

  • Community Hospitals of Indianapolis - Regional Cancer Center

    Indianapolis, Indiana, 46219

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • Romagosa Radiation Oncology Center

    Lafayette, Louisiana, 70501

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40511-1093

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology

    Louisville, Kentucky, 40215

  • Virginia Baptist Hospital

    Lynchburg, Virginia, 24503

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Merle M. Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Health First Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee, 38117

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38163

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • East Jefferson General Hospital

    Metairie, Louisiana, 70011

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • South Jersey Hospital - Millville

    Millville, New Jersey, 08332

  • St. Joseph's Hospital

    Milwaukee, Wisconsin, 53210

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • UNI-MED Medical Center

    Minot, North Dakota, 58701

  • Urology Associates - Mobile AL

    Mobile, Alabama, 36640

  • MBCCOP - University of South Alabama

    Mobile, Alabama, 36688

  • Alabama Oncology, LLC

    Montgomery, Alabama, 36106-2801

  • Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Kaplan Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Whittingham Cancer Center

    Norwalk, Connecticut, 06856

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Florida Radiation Oncology Group

    Orange Park, Florida, 32073

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Western Baptist Hospital

    Paducah, Kentucky, 42001

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • West Florida Cancer Institute - Pensacola

    Pensacola, Florida, 32514

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Allegheny University Hospitals- Hahnemann

    Philadelphia, Pennsylvania, 19102-1192

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Veterans Affairs Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Cancer Care Center

    Pomona, California, 91767

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Vassar Brothers Hospital

    Poughkeepsie, New York, 12601

  • Southeastern Wisconsin Regional Cancer Center

    Racine, Wisconsin, 53405

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Mercy Medical Center - Redding

    Redding, California, 96099-6009

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Genesee Hospital - Rochester

    Rochester, New York, 14607

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • InterCommunity Cancer Center at Rome

    Rome, Georgia, 30161

  • Green Mountain Oncology Group

    Rutland, Vermont, 05701

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • St. Mary's Medical Center

    Saginaw, Michigan, 48601

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Santa Cruz Radiation Oncology Medical Group, Inc.

    Santa Cruz, California, 95065

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Swedish Hospital Tumor Institute

    Seattle, Washington, 98104

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Grand View Hospital

    Sellersville, Pennsylvania, 18960

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • St. Joseph's Radiation Oncology Center

    South Bend, Indiana, 46617

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • CCOP - Central Illinois

    Springfield, Illinois, 62526

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • CCOP - Ozarks Regional

    Springfield, Missouri, 65807

  • Veterans Affairs Medical Center - Saint Louis

    St Louis, Missouri, 63106

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Bayfront Medical Center

    St. Petersburg, Florida, 33701

  • Stanford University

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • St. John Medical Center

    Tulsa, Oklahoma, 74104

  • Radiation Oncology Associates of West Alabama

    Tuscallosa, Alabama, 35401

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • South Georgia Medical Center

    Valdosta, Georgia, 31603

  • New York Medical College

    Valhalla, New York, 10595

  • Radiation Oncology Center - Walnut Creek

    Walnut Creek, California, 94598

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Schiffler Oncology Center

    Wheeling, West Virginia, 26003

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • Wilkes Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • York Hospital

    York, Pennsylvania, 17315

Other trials in United States

Canada16 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W-W1T8

  • Ottawa Regional Cancer Centre - Civic Campus

    Ottawa, Ontario, K1Y 4K7

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

About this study

Official title: A PHASE I/II TRIAL TO EVALUATE BRACHYTHERAPY AS THE SOLE METHOD OF RADIATION THERAPY FOR STAGE I AND II BREAST CARCINOMA

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer.

Read the detailed description

OBJECTIVES: I. Evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local cancer control rate experience with brachytherapy used as the sole method of radiotherapy in women with stage I/II breast cancer treated with tylectomy who have histologically assessed negative surgical margins, less than 4 positive axillary nodes, and no extracapsular nodal extension or extensive intraductal component. II. Reduce the total treatment time of breast irradiation from 6 weeks to 4-5 days in these patients.

OUTLINE: Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery. All patients receive brachytherapy to the target volume (as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin) using iridium-192 implants for dose distribution to five planes. Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institution's discretion. Patients are followed at 2 and 6 weeks after treatment, then at 3, 6, 9 and 12 months, then every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued in each group (high-dose rate vs low-dose rate) over 2 years.

Conditions
Breast Cancer
Being tested
brachytherapy
Keywords
stage I breast cancer, stage II breast cancer, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, invasive ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma
Medical subject headings
Breast Neoplasms, Carcinoma, Ductal, Breast

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brachytherapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2004 (estimated)
  2. Study startMay 1997
  3. Primary completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002873
Sponsor's protocol ID
RTOG-9517
Other IDs
CDR0000065157
Status last verified
Feb 2008
First submitted
1 Nov 1999
Last updated
19 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Arthur DW, Winter K, Kuske RR, Bolton J, Rabinovitch R, White J, Hanson WF, Wilenzick RM, McCormick B. A Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):467-73. doi: 10.1016/j.ijrobp.2007.12.056. Epub 2008 Mar 4.

    PubMed 18294778

  • Ibbott GS, Hanson WF, O'Meara E, Kuske RR, Arthur D, Rabinovitch R, White J, Wilenzick RM, Harris I, Tailor RC. Dose specification and quality assurance of radiation therapy oncology group protocol 95-17; a cooperative group study of iridium-192 breast implants as sole therapy. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1572-8. doi: 10.1016/j.ijrobp.2007.08.011.

    PubMed 18035213

  • Rabinovitch R, Winter K, Kuske R, Bolton J, Arthur D, Scroggins T, Vicini F, McCormick B, White J. RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma--year-5 toxicity and cosmesis. Brachytherapy. 2014 Jan-Feb;13(1):17-22. doi: 10.1016/j.brachy.2013.08.002. Epub 2013 Sep 14.

    PubMed 24041956

  • Kuske RR, Winter K, Arthur DW, et al.: A phase II trial of brachytherapy alone following lumpectomy for stage I or II breast cancer: initial outcomes of RTOG 9517. [Abstract] J Clin Oncol 22 (Suppl 14): A-565, 18s, 2004.

  • Kuske RR, Winter K, Arthur D, et al.: A phase I/II trial of brachytherapy alone following lumpectomy for select breast cancer: toxicity analysis of Radiation Therapy Oncology Group 95-17. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-151, 87, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing brachytherapy in people with Breast Cancer, run by Radiation Therapy Oncology Group at 232 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002873, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.

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