Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Tomotherapy

• Registration Number: NCT02858934
• Lead Sponsor: Andre Nazac

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.

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-08
• Study Start: 2017-03-08
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
preoperative tomotherapy	Tomotherapy	This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer, including approximately 24 women. Radiotherapy will be performed in 1 week and before the surgery in stead of following surgery.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.

Primary Outcome Measures

Name	Time	Method
Quantity of blood lost	from 2 to 8 days after the last radiotherapy session.	Quantity of blood that has been lost during the breast conservation surgery, performed 2 to 8 days after the last radiotherapy session.
Wound infection (yes/no)	up to 30 days post operative	Presence of wound infection, defined as: purulent drainage, cellulitis, abscess or wound requiring drainage, debriding, and antibiotics associated with a clinical diagnosis of infection.
Number of adverse events	up to three months after radiotherapy start	Acute radiation toxicity measure
Dindo score	Week 6 after radiotherapy start	Post operative morbidity assessment according to Dindo, Demartines et al.
Duration of the surgical procedure	from 2 to 8 days after the last radiotherapy session.	Duration of the breast conserving surgery (lumpectomy + sentinel lymph node procedure)
Wound disruption (yes/no)	up to 30 days post operative	Presence of wound disruption defined as skin dehiscence from any cause including seroma or hematoma.

Secondary Outcome Measures

Name	Time	Method
QLQ-C30 questionnaire	week 6 after radiotherapy start	Assessment of the quality of life, according to the QLQC30 questionnaire
EORTC QLQ-BR23 questionnaire	week 6 after radiotherapy start	Assessment of the quality of life, according to the EORTC BR23 questionnaire
Number of adverse events	from three months after radiotherapy start till end of study (up to 1 years)	Late toxicity measure
Local recurrence (yes/no)	up till the end of study (1 year)	Local control: presence of local cancer recurrence

Trial Locations

Locations (3)

UZ Brussel; 🇧🇪 Brussels, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium

AZ Sint Blasius; 🇧🇪 Dendermonde, Belgium