Breast Cancer
Conditions
Keywords
IORT, Boost, Breast cancer, Local recurrence, Toxicity, LENT SOMA, TARGIT, Quality Control Registry
Brief summary
Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT
Detailed description
Quality Control Registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = \>1000 patients is planned.
Interventions
RADIATIONIORT with 20 Gy
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
Sponsors
Universitätsmedizin Mannheim
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Tumor diameter \< 3,5 cm * Informed consent
Exclusion criteria
* No informed consent * Tumor size \> 3,5 cm * No indication for a boost
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Local Recurrence | 5 years | The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost | 84 months | Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) and oncological data took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IORT Boost With 20 Gy and Standard Whole Breast Irradition All patients gave their informed consent prior to surgery and were planned for an anticipated boost immediately after tumor resection. Additionally, all patients were planned for standard whole breast radiotherapy with external beam radiation (EBRT). IORT with low-kV x-rays was given immediately after tumor resection into the tumorbed with 12-20 Gy as a single fraction with the INTRABEAM® system. EBRT was given according to standard of care procedures with conventional or hypofractioned schedules. | 902 |
| Total | 902 |
Baseline characteristics
| Characteristic | IORT Boost With 20 Gy and Standard Whole Breast Irradition | — |
|---|---|---|
| Age, Continuous | 61 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 902 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 902 |
| other Total, other adverse events | 83 / 902 |
| serious Total, serious adverse events | 0 / 902 |
Outcome results
Primary
Number of Patients With Local Recurrence
The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate
Time frame: 5 years
Population: Planned IORT Boost plus whole breast irradiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IORT Boost | Number of Patients With Local Recurrence | 10 participants |
Secondary
Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost
Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) and oncological data took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs).
Time frame: 84 months
Population: Chronic higher grade fibrosis was defined as fibrosis grade 2 or higher occuring at least 3 times during follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IORT Boost | Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost | 132 Participants |