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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00072293
Registration number
NCT00072293
Ethics application status
Date submitted
4/11/2003
Date registered
6/11/2003
Date last updated
23/01/2018
Titles & IDs
Public title
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
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Scientific title
A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
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Secondary ID [1]
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IBCSG 23-01
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Secondary ID [2]
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CDR0000339581
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Universal Trial Number (UTN)
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Trial acronym
23-01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Axillary lymph node dissection
Treatment: Surgery - No axillary lymph node dissection
Active comparator: Axillary Dissection - Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Experimental: No Axillary Dissection - Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
Treatment: Surgery: Axillary lymph node dissection
Axillary lymph node dissection
Treatment: Surgery: No axillary lymph node dissection
Therapeutic conventional surgery
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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5-year Disease-Free Survival
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Assessment method [1]
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Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.
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Timepoint [1]
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5-year estimate reported after a median follow-up of 60 months
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Secondary outcome [1]
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5-year Overall Survival
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Assessment method [1]
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Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.
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Timepoint [1]
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5-year estimate reported after a median follow-up of 60 months
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Secondary outcome [2]
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Site of Recurrence
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Assessment method [2]
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Site of recurrence of breast cancer
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Timepoint [2]
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Reported after a median follow-up of 60 months
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
* Largest tumor lesion = 5 cm
* Palpable or nonpalpable breast lesion
* Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions
* Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
* At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension
* No clinical evidence of distant metastases
* No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:
* Skeletal pain of unknown cause
* Elevated alkaline phosphatase
* Bone scan showing hot spots
* No palpable axillary lymph node(s)
* No Paget's disease without invasive cancer
* Hormone receptor status:
* Estrogen receptor and progesterone receptor known
PATIENT CHARACTERISTICS:
Age
* Any age
Sex
* Female
Menopausal status
* Any status
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* See Disease Characteristics
Renal
* Not specified
Other
* Not pregnant or nursing
* No other prior or concurrent malignancy except the following:
* Adequately treated basal cell or squamous cell skin cancer
* Adequately treated carcinoma in situ of the cervix
* Adequately treated in situ melanoma
* Contralateral or ipsilateral carcinoma in situ of the breast
* No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
* Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No prior systemic therapy for breast cancer
* More than 1 year since prior chemopreventive agent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2017
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Sample size
Target
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Accrual to date
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Final
931
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Lismore Base Hospital - Lismore
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Recruitment hospital [2]
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St Vincents Hospital - Lismore
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Recruitment hospital [3]
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Mater Hospital - North Sydney - North Sydney
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Recruitment hospital [4]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [5]
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Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [6]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment hospital [7]
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Recruitment hospital [8]
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Royal Adelaide Hospital Cancer Centre - Adelaide
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Recruitment hospital [9]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [10]
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St. John of God Hospital - Bunbury - Bunbury
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Recruitment postcode(s) [1]
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2480 - Lismore
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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2065 - St. Leonards
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Recruitment postcode(s) [4]
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2050 - Sydney
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Recruitment postcode(s) [5]
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2650 - Wagga Wagga
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment postcode(s) [9]
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6230 - Bunbury
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Recruitment outside Australia
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Belgium
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Liege
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Brazil
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Rio Grande Do Sul
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Denmark
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Horsholm
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France
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Villejuif
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Italy
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Aviano
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Ferrara
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Italy
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Lecco
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Italy
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Milan
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Italy
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Pavia
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Peru
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Lima
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Slovenia
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Ljubljana
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Switzerland
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Aarau
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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Lausanne
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Switzerland
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State/province [20]
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St. Gallen
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Funding & Sponsors
Primary sponsor type
Other
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Name
ETOP IBCSG Partners Foundation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.
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Trial website
https://clinicaltrials.gov/study/NCT00072293
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Trial related presentations / publications
Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5. Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254.
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Public notes
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Contacts
Principal investigator
Name
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Viviana E. Galimberti
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Address
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European Institute of Oncology
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00072293
Download to PDF