Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

• Sponsor: Medical University of Graz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04535895
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 64.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Radiotherapy Side Effect	Radiation: Simultaneous integrated boost	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.
• Actual Study Start Date: Apr 16, 2020
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simultaneous integrated boost arm	Radiation: Simultaneous integrated boost; Adjuvant breast cancer irradiation including simultaneous integrated boost

Outcome Measures

Primary Outcome Measures

1. Acute Radiation induced toxicity (grade 2 or higher) [Measurement at the last 1 day of radiotherapy]

   Toxicity score using Common Terminology for Adverse Events (CTCAE)

2. Acute Radiation induced toxicity (grade 2 or higher) [Measurement 3 months after completion of radiotherapy]

   Toxicity score using Common Terminology for Adverse Events (CTCAE)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• Incomplete tumor resection

• Mastectomy

• Distant metastases at diagnosis

• Unable to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8036

Sponsors and Collaborators

• Medical University of Graz

Investigators

• Principal Investigator: Tanja Langsenlehner, MD, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT04535895
• Other Study ID Numbers: 1094/2020
• First Posted: Sep 2, 2020
• Last Update Posted: Apr 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 14, 2021