Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

NCT ID: NCT04535895

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Radiotherapy Side Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simultaneous integrated boost arm

Group Type EXPERIMENTAL

Simultaneous integrated boost

Intervention Type RADIATION

Adjuvant breast cancer irradiation including simultaneous integrated boost

Interventions

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Simultaneous integrated boost

Adjuvant breast cancer irradiation including simultaneous integrated boost

Intervention Type RADIATION

Eligibility Criteria

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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

* Incomplete tumor resection
* Mastectomy
* Distant metastases at diagnosis
* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanja Langsenlehner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 22280808 (View on PubMed)

Other Identifiers

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1094/2020

Identifier Type: -

Identifier Source: org_study_id

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