NCT01948726

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

August 23, 2013

Last Update Submit

August 19, 2021

Conditions

Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost

Keywords

Breast cancerHypofractionationSimultaneous integrated boostToxicity

Outcome Measures

Primary Outcomes (1)

  • Acute Skin Toxicity

    Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

    6 months

Secondary Outcomes (4)

  • Number of Patients treated on Protocol

    22-29 days (16 fractions)

  • Acute General Toxicity

    0 to 6 months

  • Quality of life Score

    0 to 6 months

  • Performance

    0 to 6 months

Other Outcomes (1)

  • Skin toxicity (Cosmetic results)

    0 to 6 months

Study Arms (1)

Hypofractionation with SIB

EXPERIMENTAL
Radiation: Hypofractionation with simultaneous integrated boost

Interventions

Hypofractionation with simultaneous integrated boostRADIATION
Hypofractionation with SIB

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Charité University Medical Center Berlin

Berlin, 10117, Germany

Location

Krankenhaus Buchholz

Buchholz, 21244, Germany

Location

Klinikum des Landkreises Deggendorf Mammazentrum

Deggendorf, 94469, Germany

Location

Praxis für Strahlentherapie am Krankenhaus Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

Malteser St. Franziskus-Hospital

Flensburg, 24939, Germany

Location

Onkologischer Schwerpunkt (OSP) Goeppingen

Göppingen, 73006, Germany

Location

Strahlenzentrum Hamburg Nord

Hamburg, 22419, Germany

Location

Radiologie and Radioonkologie

Hamburg, 22767, Germany

Location

University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Kiel

Kiel, 24105, Germany

Location

University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Luebeck

Lübeck, 23538, Germany

Location

MGZ Luebeck im Hochschulstadtteil

Lübeck, 23562, Germany

Location

Staedtisches Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

University Medical Center Mainz, Department of Radiotherapy

Mainz, 55131, Germany

Location

University Medical Center Rechts der Isar Department of Radiotherapy Muenchen

München, 81675, Germany

Location

Radiology Pinneberg

Pinneberg, 25421, Germany

Location

Helios Kliniken Schwerin

Schwerin, 19049, Germany

Location

Johanniter-Krankenhaus Genthin-Stendal

Stendal, 39576, Germany

Location

MVZ Klinikum Straubing GmbH

Straubing, 94315, Germany

Location

Heinrich-Braun-Klinikum Zwickau

Zwickau, 08060, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Juergen Dunst, Prof.

    University Medical Center Schleswig-Holstein (UKSH)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Juergen Dunst

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 24, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

DE(19)