Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

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%.

Study Overview

• Status: Completed
• Conditions: Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost
• Intervention / Treatment: Radiation: Hypofractionation with simultaneous integrated boost

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité University Medical Center Berlin
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz
  • Deggendorf, Germany, 94469
    • Klinikum des Landkreises Deggendorf Mammazentrum
  • Dresden, Germany, 01067
    • Praxis für Strahlentherapie am Krankenhaus Dresden-Friedrichstadt
  • Flensburg, Germany, 24939
    • Malteser St. Franziskus-Hospital
  • Göppingen, Germany, 73006
    • Onkologischer Schwerpunkt (OSP) Goeppingen
  • Hamburg, Germany, 22419
    • Strahlenzentrum Hamburg Nord
  • Hamburg, Germany, 22767
    • Radiologie and Radioonkologie
  • Kiel, Germany, 24105
    • University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Kiel
  • Luebeck, Germany, 23538
    • University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Luebeck
  • Luebeck, Germany, 23562
    • MGZ Luebeck im Hochschulstadtteil
  • Lueneburg, Germany, 21339
    • Staedtisches Klinikum Lueneburg
  • Mainz, Germany, 55131
    • University Medical Center Mainz, Department of Radiotherapy
  • Muenchen, Germany, 81675
    • University Medical Center Rechts der Isar Department of Radiotherapy Muenchen
  • Pinneberg, Germany, 25421
    • Radiology Pinneberg
  • Schwerin, Germany, 19049
    • Helios Kliniken Schwerin
  • Stendal, Germany, 39576
    • Johanniter-Krankenhaus Genthin-Stendal
  • Straubing, Germany, 94315
    • MVZ Klinikum Straubing GmbH
  • Zwickau, Germany, 08060
    • Heinrich-Braun-Klinikum Zwickau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionation with SIB	Radiation: Hypofractionation with simultaneous integrated boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Skin Toxicity	Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients treated on Protocol	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	22-29 days (16 fractions)
Acute General Toxicity	All dimensions of NCI-CTCAE	0 to 6 months
Quality of life Score	EORTC QLQ-C30, -BR23	0 to 6 months
Performance	ECOG	0 to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin toxicity (Cosmetic results)	NCI-CTCAE	0 to 6 months

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: University of Luebeck
• Investigators: Study Chair: Juergen Dunst, Prof., University Medical Center Schleswig-Holstein (UKSH)

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer; Toxicity; Hypofractionation; Simultaneous integrated boost
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ARO 2013-04