NCT Number: NCT01948726
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%.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Charité University Medical Center Berlin, Berlin, Germany
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Acute Skin Toxicity
Time frame: 6 months
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Secondary outcomes
-
Number of Patients treated on Protocol
Time frame: 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
Time frame: 0 to 6 months
All dimensions of NCI-CTCAE
-
Quality of life Score
Time frame: 0 to 6 months
EORTC QLQ-C30, -BR23
-
Performance
Time frame: 0 to 6 months
ECOG
Other outcomes
-
Skin toxicity (Cosmetic results)
Time frame: 0 to 6 months
NCI-CTCAE
Sponsors and collaborators
Lead sponsor
University Hospital Schleswig-Holstein
Other
Collaborators
- University of Luebeck
Registry information
Official study title
Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 24, 2013
- Registry last updated
- Aug 26, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery
NCT02654119
Breast Diseases, Breast Neoplasms
Norfolk, Nebraska, United States
View Trial DetailsTumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAfrican Cancer Genome: GMD
NCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial Details24GUT540 : Meeting of Breast Cancer Patients and Pathologists
NCT07040514
Breast Cancer, Breast Diseases
Lebanon, New Hampshire, United States
View Trial Details