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NCT Number: NCT02858934

Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tomotherapy

Radiation

Dose prescription:

Whole breast irradiation: 25 Gy in 5 daily fractions of 5 Gy Boost: 30 Gy in 5 daily fractions of 6 Gy The boost will be delivered as a simultaneous integrated boost (SIB).

Target volumes:

Clinical target volume (CTV) breast: defined by the soft tissue of the breast down to the pectoralis fascia, but excluding the skin and the underlying muscle, ribs, lung and heart.

Gross tumor volume (GTV) boost: includes all gross tumor volume, as visible on computer tomography, mammography and/or magnetic resonance imaging (MRI). MRI imaging is preferentially performed in treatment position.

CTV boost: includes the primary tumor, with a margin of 1.0 cm in all directions to encompass potential microscopic disease extension. The CTV boost excludes the skin, pectoralis muscle, ribs, lung and heart.

Planning target volume (PTV): CTV plus a margin of 5 mm in all directions, but limited at 5 mm below the skin surface.

Primary outcomes

  1. Duration of the surgical procedure

    Time frame: from 2 to 8 days after the last radiotherapy session.

    Duration of the breast conserving surgery (lumpectomy + sentinel lymph node procedure)

  2. Quantity of blood lost

    Time frame: 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.

  3. Dindo score

    Time frame: Week 6 after radiotherapy start

    Post operative morbidity assessment according to Dindo, Demartines et al.

  4. Wound disruption (yes/no)

    Time frame: up to 30 days post operative

    Presence of wound disruption defined as skin dehiscence from any cause including seroma or hematoma.

  5. Wound infection (yes/no)

    Time frame: 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.

  6. Number of adverse events

    Time frame: up to three months after radiotherapy start

    Acute radiation toxicity measure

Secondary outcomes

  1. QLQ-C30 questionnaire

    Time frame: week 3 after radiotherapy start

    Assessment of the quality of life, according to the QLQC30 questionnaire

  2. QLQ-C30 questionnaire

    Time frame: week 6 after radiotherapy start

    Assessment of the quality of life, according to the QLQC30 questionnaire

  3. EORTC QLQ-BR23 questionnaire

    Time frame: week 3 after radiotherapy start

    Assessment of the quality of life, according to the EORTC BR23 questionnaire

  4. EORTC QLQ-BR23 questionnaire

    Time frame: week 6 after radiotherapy start

    Assessment of the quality of life, according to the EORTC BR23 questionnaire

  5. Number of adverse events

    Time frame: from three months after radiotherapy start till end of study (up to 1 years)

    Late toxicity measure

  6. Local recurrence (yes/no)

    Time frame: up till the end of study (1 year)

    Local control: presence of local cancer recurrence

Sponsors and collaborators

Lead sponsor

Andre Nazac

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2016
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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