Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002851 |
Recruitment Status : Unknown
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 29, 2010
|
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | November 1, 1999 | ||||||||||||
First Posted Date ICMJE | January 27, 2003 | ||||||||||||
Last Update Posted Date | January 29, 2010 | ||||||||||||
Study Start Date ICMJE | July 1996 | ||||||||||||
Primary Completion Date | Not Provided | ||||||||||||
Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed | ||||||||||||
Official Title ICMJE | PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER | ||||||||||||
Brief Summary | RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed. |
||||||||||||
Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.
Patients are followed at least yearly after randomization for up to 20 years. PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years. |
||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
||||||||||||
Condition ICMJE | Breast Cancer | ||||||||||||
Intervention ICMJE |
|
||||||||||||
Study Arms ICMJE | Not Provided | ||||||||||||
Publications * |
|
||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Unknown status | ||||||||||||
Estimated Enrollment ICMJE |
4000 | ||||||||||||
Original Enrollment ICMJE | Not Provided | ||||||||||||
Study Completion Date ICMJE | Not Provided | ||||||||||||
Primary Completion Date | Not Provided | ||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||||||||||
Sex/Gender ICMJE |
|
||||||||||||
Ages ICMJE | up to 75 Years (Child, Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Belgium, Bosnia and Herzegovina, Chile, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, Turkey, United Kingdom | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00002851 | ||||||||||||
Other Study ID Numbers ICMJE | CDR0000065094 EORTC-10925 EORTC-22922 |
||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Current Responsible Party | Not Provided | ||||||||||||
Original Responsible Party | Same as current | ||||||||||||
Current Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
|
||||||||||||
PRS Account | National Cancer Institute (NCI) | ||||||||||||
Verification Date | December 2004 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |