Breast Cancer Clinical Trial
Official title:
Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer
Verified date | July 2022 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The standard treatment for women with a relatively small breast cancer without arguments for involvement of the axillary lymph nodes, is breast conserving surgery followed by radiotherapy of the whole breast, often with a complementary dose to the operated area (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality of life. Randomized trials have shown that shorter schedules, delivering slightly more dose per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the investigators have tested such a short schedule and shown that it is equally safe and equally well tolerated as the conventional schemes. Other hospitals have examined (and still are examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1 week. This clinical study involves delivering radiotherapy in 1 week and before the surgery in stead of following surgery. In the postoperative setting, it is often debatable which volume should be included in the boost. Often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period. This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 3, 2022 |
Est. primary completion date | March 3, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Histological diagnosis of unifocal invasive breast carcinoma, no special type (ductal carcinoma) - Tumor Staging: cT1-2N0M0 - Luminal A or B - Candidate for breast conserving surgery - N0-status confirmed by lymph node cytology Exclusion Criteria: - Multifocal/multicentric disease - Prior thoracic radiotherapy - Pregnancy - SBR3 grading - Triple negative status which benefit neoadjuvant chemotherapy |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels | |
Belgium | UZ Brussel | Brussels | |
Belgium | AZ Sint Blasius | Dendermonde |
Lead Sponsor | Collaborator |
---|---|
Andre Nazac |
Belgium,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of the surgical procedure | Duration of the breast conserving surgery (lumpectomy + sentinel lymph node procedure) | from 2 to 8 days after the last radiotherapy session. | |
Primary | Quantity of blood lost | Quantity of blood that has been lost during the breast conservation surgery, performed 2 to 8 days after the last radiotherapy session. | from 2 to 8 days after the last radiotherapy session. | |
Primary | Dindo score | Post operative morbidity assessment according to Dindo, Demartines et al. | Week 6 after radiotherapy start | |
Primary | Wound disruption (yes/no) | Presence of wound disruption defined as skin dehiscence from any cause including seroma or hematoma. | up to 30 days post operative | |
Primary | Wound infection (yes/no) | Presence of wound infection, defined as: purulent drainage, cellulitis, abscess or wound requiring drainage, debriding, and antibiotics associated with a clinical diagnosis of infection. | up to 30 days post operative | |
Primary | Number of adverse events | Acute radiation toxicity measure | up to three months after radiotherapy start | |
Secondary | QLQ-C30 questionnaire | Assessment of the quality of life, according to the QLQC30 questionnaire | week 3 after radiotherapy start | |
Secondary | QLQ-C30 questionnaire | Assessment of the quality of life, according to the QLQC30 questionnaire | week 6 after radiotherapy start | |
Secondary | EORTC QLQ-BR23 questionnaire | Assessment of the quality of life, according to the EORTC BR23 questionnaire | week 3 after radiotherapy start | |
Secondary | EORTC QLQ-BR23 questionnaire | Assessment of the quality of life, according to the EORTC BR23 questionnaire | week 6 after radiotherapy start | |
Secondary | Number of adverse events | Late toxicity measure | from three months after radiotherapy start till end of study (up to 1 years) | |
Secondary | Local recurrence (yes/no) | Local control: presence of local cancer recurrence | up till the end of study (1 year) |
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