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Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer

NCT01299987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms
  • Breast Diseases
  • Neoplasm Recurrence, Local
  • Neoplasms

Interventions

RADIATION

intraoperative radiotherapy

intraoperative single dose radiotherapy (20 Gy)

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Sperk Elena, MD · Medical Faculty Mannheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299987 on ClinicalTrials.gov