Clinical trial NCT02858934: Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer
Official title: Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Short preoperative tomotherapy
Radiotherapy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Women with early breast cancer are treated with breast conserving surgery (BCS) followed by whole breast irradiation (WBI) and a complementary dose to the lumpectomy cavity (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, WBI plus boost are delivered in 6-7 weeks. This treatment is associated with fatigue and a decreased quality of life. Randomized trials have shown that shorter hypofractionated schedules, delivering radiotherapy in 3 weeks, are equal to the long schedules. The investigators have shown that a hypofractionated tomotherapy with a simultaneous integrated boost is oncologically safe, well tolerated and has less impact on quality of life than the conventional schemes.

In the postoperative setting, it is often debatable which volume should be included in the boost. Surgical clips can help to decrease inter-observer variability, but often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the gross tumor volume (GTV) is visible on imaging. This can result in smaller boost volumes.

The aim of this study is to investigate the feasibility of a short preoperative tomotherapy. The potential benefits are

* a decrease in overall treatment time
* a positive effect on quality of life
* a more precise target delineation
* profitable health economics.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of the surgical procedure
timeFrame: from 2 to 8 days after the last radiotherapy session.
measure: Quantity of blood lost
timeFrame: from 2 to 8 days after the last radiotherapy session.
measure: Dindo score
timeFrame: Week 6 after radiotherapy start
measure: Wound disruption (yes/no)
timeFrame: up to 30 days post operative
measure: Wound infection (yes/no)
timeFrame: up to 30 days post operative
measure: Number of adverse events
timeFrame: up to three months after radiotherapy start
Secondary outcomes:
measure: QLQ-C30 questionnaire
timeFrame: week 3 after radiotherapy start
measure: QLQ-C30 questionnaire
timeFrame: week 6 after radiotherapy start
measure: EORTC QLQ-BR23 questionnaire
timeFrame: week 3 after radiotherapy start
measure: EORTC QLQ-BR23 questionnaire
timeFrame: week 6 after radiotherapy start
measure: Number of adverse events
timeFrame: from three months after radiotherapy start till end of study (up to 1 years)
measure: Local recurrence (yes/no)
timeFrame: up till the end of study (1 year)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: UZ Brussel
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
Study officials:
affiliation: CHU Brugmann/UZ Brussel
name: Mark De Ridder, MD
role: PRINCIPAL_INVESTIGATOR
References:
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