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WithdrawnNCT04535895Updated Oct 12, 2022

Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

An interventional study of Simultaneous integrated boost in Breast Cancer and Radiotherapy Side Effect, sponsored by Medical University of Graz. Withdrawn at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Treatment standard has changed

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2020, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.

Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.

The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.

02

Conditions studied

  • Breast Cancer
  • Radiotherapy Side Effect

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03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Invasive breast cancer or ductal carcinoma in situ
  • Breast conserving surgery
  • Complete tumor resection
  • Treatment with adjuvant radiotherapy of the breast
  • Indication for boost Irradiation
  • Given informed consent

Exclusion criteria

Exclusion Criteria:

  • Incomplete tumor resection
  • Mastectomy
  • Distant metastases at diagnosis
  • Unable to give informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Simultaneous integrated boost arm

    Radiation: Simultaneous integrated boost

Interventions

  • RadiationSimultaneous integrated boost

    Adjuvant breast cancer irradiation including simultaneous integrated boost

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What researchers measure

Primary outcomes

  1. Acute Radiation induced toxicity (grade 2 or higher)

    Toxicity score using Common Terminology for Adverse Events (CTCAE)

    Time frame: Measurement at the last 1 day of radiotherapy

  2. Acute Radiation induced toxicity (grade 2 or higher)

    Toxicity score using Common Terminology for Adverse Events (CTCAE)

    Time frame: Measurement 3 months after completion of radiotherapy

07

Study locations

1 site
  • Medical University of Graz
    Graz, 8036, Austria
08

References and documents

Publications

  • Hurkmans CW, Dijckmans I, Reijnen M, van der Leer J, van Vliet-Vroegindeweij C, van der Sangen M. Adaptive radiation therapy for breast IMRT-simultaneously integrated boost: three-year clinical experience. Radiother Oncol. 2012 May;103(2):183-7. doi: 10.1016/j.radonc.2011.12.014. Epub 2012 Jan 24. PubMed 22280808 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04535895
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Sep 2, 2020
Start date
Apr 16, 2020
Primary completion
Aug 31, 2022 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Oct 12, 2022

Study contacts

Tanja Langsenlehner, MD
principal investigator · Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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