Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost
• Interventions: Radiation: Hypofractionation with simultaneous integrated boost

• Registration Number: NCT01948726
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies.

Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.

Detailed Description

Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).

Study Timeline

• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-24
• Study Start: 2013-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
• Indication to adjuvant radiotherapy including boost radiotherapy
• Clearly identified primary tumor region preferably by radiopaque clips
• Primary wound healing after breast conserving therapy without signs of infection
• Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
• Written informed consent

Exclusion Criteria

• Patients operated by mastectomy
• No indication for boost radiation
• Resection margins positive for disease or insufficient identification of the boost volume
• Indication for radiotherapy of the regional lymph nodes
• History of prior breast or thoracic radiotherapy
• Extended postoperative seroma at the beginning of radiotherapy
• Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
• Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionation with SIB	Hypofractionation with simultaneous integrated boost	-

Primary Outcome Measures

Name	Time	Method
Acute Skin Toxicity	6 months	Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

Secondary Outcome Measures

Name	Time	Method
Performance	0 to 6 months	ECOG
Number of Patients treated on Protocol	22-29 days (16 fractions)	Dose constraints Dmedian lung \< 10 Gy; Dmedian heart \< 5 Gy, Dmax ≤ 40 Gy; Dmedian anterior branch of the left coronary artery (LAD, RIVA) \< 15 Gy, Dmax ≤ 40 Gy; Dmedian contralateral breast \< 3 Gy
Acute General Toxicity	0 to 6 months	All dimensions of NCI-CTCAE
Quality of life Score	0 to 6 months	EORTC QLQ-C30, -BR23

Trial Locations

Locations (19)

Strahlenzentrum Hamburg Nord; 🇩🇪 Hamburg, Germany

Klinikum des Landkreises Deggendorf Mammazentrum; 🇩🇪 Deggendorf, Germany

University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Kiel; 🇩🇪 Kiel, Germany

University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Luebeck; 🇩🇪 Luebeck, Germany

MGZ Luebeck im Hochschulstadtteil; 🇩🇪 Luebeck, Germany

Staedtisches Klinikum Lueneburg; 🇩🇪 Lueneburg, Germany

University Medical Center Rechts der Isar Department of Radiotherapy Muenchen; 🇩🇪 Muenchen, Germany

University Medical Center Mainz, Department of Radiotherapy; 🇩🇪 Mainz, Germany

Radiology Pinneberg; 🇩🇪 Pinneberg, Germany

Helios Kliniken Schwerin; 🇩🇪 Schwerin, Germany

Johanniter-Krankenhaus Genthin-Stendal; 🇩🇪 Stendal, Germany

MVZ Klinikum Straubing GmbH; 🇩🇪 Straubing, Germany

Heinrich-Braun-Klinikum Zwickau; 🇩🇪 Zwickau, Germany

Charité University Medical Center Berlin; 🇩🇪 Berlin, Germany

Malteser St. Franziskus-Hospital; 🇩🇪 Flensburg, Germany

Radiologie and Radioonkologie; 🇩🇪 Hamburg, Germany

Praxis für Strahlentherapie am Krankenhaus Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Onkologischer Schwerpunkt (OSP) Goeppingen; 🇩🇪 Göppingen, Germany

Krankenhaus Buchholz; 🇩🇪 Buchholz, Germany