Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT04913532
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04913532
Study Brief:
Protocol Section:
NCT04913532