NCT01024582

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 27, 2017

Status Verified

March 1, 2017

Enrollment Period

7.3 years

First QC Date

December 2, 2009

Last Update Submit

September 26, 2017

Conditions

Breast Cancer

Keywords

breast cancerinvasive breast canceradenocarcinoma of the breast

Outcome Measures

Primary Outcomes (1)

  • local recurrence

    Local recurrences should not exceed 4% at 5 years of follow-up

    5 years

Secondary Outcomes (3)

  • breast fibrosis

    5 years

  • cosmetic outcome

    5 years

  • Pathological response

    6 weeks after finishing iradiation treatment

Study Arms (1)

accelerated partial breast irradiation

EXPERIMENTAL

pre-operative radiation of the in situ tumor in the breast

Procedure: biopsyProcedure: fine-needle aspirationRadiation: accelerated partial breast irradiationRadiation: image-guided radiation therapy

Interventions

biopsyPROCEDURE

before treatment a biopsy will be taken to confirm breast cancer type

accelerated partial breast irradiation
fine-needle aspirationPROCEDURE

at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis

accelerated partial breast irradiation
accelerated partial breast irradiationRADIATION
accelerated partial breast irradiation
image-guided radiation therapyRADIATION
accelerated partial breast irradiation

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer * Must have undergone a sentinel node procedure prior to irradiation PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 BE, Netherlands

Location

Related Publications (1)

  • van der Leij F, Bosma SC, van de Vijver MJ, Wesseling J, Vreeswijk S, Rivera S, Bourgier C, Garbay JR, Foukakis T, Lekberg T, van den Bongard DH, van Vliet-Vroegindeweij C, Bartelink H, Rutgers EJ, Elkhuizen PH. First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. Radiother Oncol. 2015 Mar;114(3):322-7. doi: 10.1016/j.radonc.2015.02.002. Epub 2015 Feb 17.

    PMID: 25701298DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BiopsyBiopsy, Fine-NeedleRadiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesBiopsy, NeedlePuncturesRadiotherapyTherapeutics

Study Officials

  • Paula Elkhuizen, MD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

September 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)