NCT01299987

Brief Summary

This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
591

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

11.8 years

First QC Date

February 18, 2011

Last Update Submit

March 25, 2025

Conditions

Breast NeoplasmsBreast DiseasesNeoplasm Recurrence, LocalNeoplasms

Keywords

Keywords provided by University Hospital Mannheim:Intraoperative RadiotherapyEarly Breast CancerElderly Patients

Outcome Measures

Primary Outcomes (1)

  • Local Relapse

    Rate of local relapse (within 2cm of the initial tumor bed)

    up to ten years

Secondary Outcomes (5)

  • Overall Survival

    up to ten years

  • Ipsi- or Contralateral Breast Cancer

    up to ten years

  • Cosmesis

    up to 7.5 years

  • General and breast-specific Quality of Life after IORT

    up to 10 years

  • Late toxicity after IORT

    up to ten years

Study Arms (1)

Intraoperative radiotherapy

EXPERIMENTAL

single arm with intraoperative radiotherapy

Radiation: intraoperative radiotherapy

Interventions

intraoperative radiotherapyRADIATION

intraoperative single dose radiotherapy (20 Gy)

Also known as: IORT
Intraoperative radiotherapy

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • cT1c cN0 cM0
  • ≥ 70 years old
  • invasive-ductal histology
  • compliance
  • informed consent

You may not qualify if:

  • extensive intraductal component (EIC)
  • multifocality /-centricity
  • lymph vessel invasion (L1)
  • clinical signs of distant metastases or clinically suspicious lymph nodes
  • other histology
  • \< 70 years old
  • missing informed consent or non-compliance
  • bilateral breast cancer at time of diagnosis
  • known BRACA 1/2 mutations (genetic testing not required)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Mannheim UMM

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (2)

  • Sperk E, Lemanski C, Neumaier C, Lauer J, Siefert V, Volker R, Lindner C, Niehoff P, Tallet AR, Racadot S, Petit A, Pazos M, Le-Blanc Onfroy M, Martin E, Reuter C, Hermann RM, Pohl F, Friedrichs K, Wurschmidt F, Pigorsch S, Kolberg HC, Graf H, Brunner TB, Malter W, Park-Simon TW, Brucker C, Fleckenstein J, Petersen C, Tuschy B, Wilken EE, Buttner S, Sutterlin M, Flyger H, Wenz F. Intraoperative radiotherapy in elderly patients with breast cancer: long-term follow-up results of the prospective phase II trial TARGIT-E. BMC Cancer. 2025 Dec 4;25(1):1862. doi: 10.1186/s12885-025-15289-0.

    PMID: 41345599DERIVED

  • Neumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171.

    PMID: 22569123DERIVED

MeSH Terms

Conditions

Breast NeoplasmsBreast DiseasesNeoplasm Recurrence, LocalNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sperk Elena, MD

    Medical Faculty Mannheim

    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
PRINCIPAL INVESTIGATOR
PI Title
Managing Director Mannheim Cancer Center Clinical Trials Unit

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

It was not planned initially back in 2011.

Locations

DE(1)