Clinical trial NCT01948726: Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Official title: Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost
Keywords: Breast cancer
Hypofractionation
Simultaneous integrated boost
Toxicity
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Luebeck
First posted: 2013-09-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Acute Skin Toxicity
timeFrame: 6 months
Secondary outcomes:
measure: Number of Patients treated on Protocol
timeFrame: 22-29 days (16 fractions)
measure: Acute General Toxicity
timeFrame: 0 to 6 months
measure: Quality of life Score
timeFrame: 0 to 6 months
measure: Performance
timeFrame: 0 to 6 months
Other outcomes:
measure: Skin toxicity (Cosmetic results)
timeFrame: 0 to 6 months
Locations:
city: Berlin
country: Germany
facility: Charité University Medical Center Berlin
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Deggendorf
country: Germany
facility: Klinikum des Landkreises Deggendorf Mammazentrum
city: Dresden
country: Germany
facility: Praxis für Strahlentherapie am Krankenhaus Dresden-Friedrichstadt
city: Flensburg
country: Germany
facility: Malteser St. Franziskus-Hospital
city: Göppingen
country: Germany
facility: Onkologischer Schwerpunkt (OSP) Goeppingen
city: Hamburg
country: Germany
facility: Strahlenzentrum Hamburg Nord
city: Hamburg
country: Germany
facility: Radiologie and Radioonkologie
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Kiel
city: Luebeck
country: Germany
facility: University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Luebeck
city: Luebeck
country: Germany
facility: MGZ Luebeck im Hochschulstadtteil
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Mainz
country: Germany
facility: University Medical Center Mainz, Department of Radiotherapy
city: Muenchen
country: Germany
facility: University Medical Center Rechts der Isar Department of Radiotherapy Muenchen
city: Pinneberg
country: Germany
facility: Radiology Pinneberg
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal
city: Straubing
country: Germany
facility: MVZ Klinikum Straubing GmbH
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum Zwickau
Study officials:
affiliation: University Medical Center Schleswig-Holstein (UKSH)
name: Juergen Dunst, Prof.
role: STUDY_CHAIR
References: