Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy (SIGNAL)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Lawson Health Research Institute
Sponsor:
Collaborators:
Laurentian University
Jewish General Hospital
Information provided by (Responsible Party):
Muriel Brackstone, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT02212860
First received: August 5, 2014
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Radiation therapy after surgery to remove breast cancer improves control of the breast cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation to the entire breast.

This clinical trial will evaluate the effectiveness of conformal radiation therapy delivered only to the area in the breast where the lumpectomy will be performed.

This study will determine if radiation therapy delivered in this manner will prevent the cancer from coming back and eliminate the need for five to six weeks of radiation.

The study will also gather information about the safety and effects (good and bad) this radiation has, and on patient satisfaction with the appearance of the breast.


Condition Intervention Phase
Early Stage Breast Carcinoma
Radiation: Stereotactic Body Radiation Then Surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial to Evaluate Single Dose Stereotactic Radiation Therapy (SBRT) Prior to Surgery for Early Stage Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Toxicity resulting from radiation treatment [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
    Toxicity resulting from radiation treatment will be collected and graded according to the Common Terminology Criteria for Adverse Events, version 4.0


Secondary Outcome Measures:
  • Cosmesis of the treated breast [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
    cosmetic result of treated breast as judged by the patient, surgeon, and radiation oncologist. Patients will self-assess cosmesis using the Modified Harvard-Harris Cosmetic Scale. The surgeon and radiation oncologist will assess cosmesis using photographs and the Modified Harvard-Harris Cosmetic Scale.

  • Disease-Free Survival [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]
    Disease recurrences will be recorded. Any tumor recurrence or death is considered a treatment failure.

  • Mastectomy-Free Survival [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]
    All surgical interventions will be recorded. Mastectomy and death will be considered treatment failures.

  • Overall Survival [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]
    Death from any cause is considered a treatment failure.


Estimated Enrollment: 120
Study Start Date: October 2014
Estimated Study Completion Date: April 2023
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radiation Then Surgery
Stereotactic image-guided neoadjuvant ablative radiation (single dose, 21 Gy) followed by lumpectomy for stage I or IIA early stage breast carcinoma
Radiation: Stereotactic Body Radiation Then Surgery
Stereotactic image-guided neoadjuvant ablative radiation (single dose, 21 Gy) followed by lumpectomy for stage I and IIA early stage breast carcinoma

Detailed Description:

Our proposal represents the convergence of several recent developments in the treatment of patients with low-risk carcinoma of the breast. For the selected subset of patients with low-risk disease, it appears that intra-operative radiotherapy with a single fraction leads to acceptable clinical outcomes in terms of local control, overall survival and toxicity. There have also been a few Phase I dose escalation trials demonstrating safety with single fraction breast radiation.

In this study, we propose the delivery of radiotherapy using only a single fraction, 21 Gy, but using stereotactic body radiation therapy. Radiation will be delivered using Volumetric-modulated arc therapy (VMAT), planned on coregistered PET/MRI and CT imaging, and delivered prone. Our approach will potentially have numerous benefits, including significantly shortened treatment time, convenience and potentially reduced health care costs. It would significantly improve the quality of life of many patients.

This study will also provide a unique opportunity for pathologic assessment of the impact of radiation at a microscopic level and on tumour markers without the confounding impact of systemic treatments, comparing pre- to post-radiation biopsy specimens for imaging and histologic predictors of radiation sensitivity.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 55 years and postmenopausal
  • Tumour size ≤3cm (i.e. stage T1/T2a) on pre-treatment imaging
  • Any grade of disease, estrogen receptor (ER) positive
  • Unicentric/unifocal disease
  • Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (medullary, papillary, colloid, mucinous, or tubular) .
  • Clinically node-negative (based upon pre-treatment physical examination & axillary ultrasound).
  • Surgical expectation that a >2mm margin can be obtained.
  • Lesion is 1cm or greater from the skin surface.
  • Able to have surgery within 1-7 days of radiation therapy.
  • Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.

Exclusion Criteria:

  • Previous radiation therapy to the same breast
  • Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
  • Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
  • Distant metastases
  • Contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
  • Prior non-hormonal therapy or radiation therapy for the current breast cancer
  • Patients with Paget's disease of the nipple.
  • Skin involvement, regardless of tumour size.
  • Patients with a breast technically unsatisfactory for radiation therapy.
  • Patients not appropriate for breast conserving surgery due to expectation of poor cosmetic result, even without radiation therapy
  • Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
  • Inability or unwillingness to provide informed consent.
  • Any other malignancy at any site (except non-melanomatous skin cancer) <5 years prior to study enrollment
  • Patients who are pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02212860

Contacts
Contact: Muriel Brackstone 519-685-8712 Muriel.Brackstone@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute Not yet recruiting
London, Ontario, Canada, N6A 4L6
Contact: Muriel Brackstone, MD, PhD    519-685-8712    Muriel.Brackstone@lhsc.on.ca   
Principal Investigator: Muriel Brackstone, MD, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Laurentian University
Jewish General Hospital
Investigators
Principal Investigator: Muriel Brackstone, MD, PhD Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Muriel Brackstone, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02212860     History of Changes
Other Study ID Numbers: SIGNAL
Study First Received: August 5, 2014
Last Updated: August 6, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
neoadjuvant
radiation
breast
cancer
hypofractionation
stereotactic
preoperative

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014