Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost Clinical Trial
Official title:
Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
| NCT number | NCT01948726 |
| Other study ID # | ARO 2013-04 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2013 |
| Est. completion date | March 2015 |
| Verified date | August 2021 |
| Source | University Hospital Schleswig-Holstein |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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%.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité University Medical Center Berlin | Berlin | |
| Germany | Krankenhaus Buchholz | Buchholz | |
| Germany | Klinikum des Landkreises Deggendorf Mammazentrum | Deggendorf | |
| Germany | Praxis für Strahlentherapie am Krankenhaus Dresden-Friedrichstadt | Dresden | |
| Germany | Malteser St. Franziskus-Hospital | Flensburg | |
| Germany | Onkologischer Schwerpunkt (OSP) Goeppingen | Göppingen | |
| Germany | Radiologie and Radioonkologie | Hamburg | |
| Germany | Strahlenzentrum Hamburg Nord | Hamburg | |
| Germany | University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Kiel | Kiel | |
| Germany | MGZ Luebeck im Hochschulstadtteil | Luebeck | |
| Germany | University Medical Center Schleswig-Holstein (UKSH), Department of Radiotherapy, Campus Luebeck | Luebeck | |
| Germany | Staedtisches Klinikum Lueneburg | Lueneburg | |
| Germany | University Medical Center Mainz, Department of Radiotherapy | Mainz | |
| Germany | University Medical Center Rechts der Isar Department of Radiotherapy Muenchen | Muenchen | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Schleswig-Holstein | University of Luebeck |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Skin toxicity (Cosmetic results) | NCI-CTCAE | 0 to 6 months | |
| Primary | Acute Skin Toxicity | Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE | 6 months | |
| Secondary | 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) | |
| Secondary | Acute General Toxicity | All dimensions of NCI-CTCAE | 0 to 6 months | |
| Secondary | Quality of life Score | EORTC QLQ-C30, -BR23 | 0 to 6 months | |
| Secondary | Performance | ECOG | 0 to 6 months |