Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy (SIGNAL)
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|ClinicalTrials.gov Identifier: NCT02212860|
Recruitment Status : Recruiting
First Posted : August 8, 2014
Last Update Posted : November 8, 2016
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 or disease||Intervention/treatment||Phase|
|Early Stage Breast Carcinoma||Radiation: Stereotactic Body Radiation Then Surgery||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Evaluate Single Dose Stereotactic Radiation Therapy (SBRT) Prior to Surgery for Early Stage Breast Carcinoma|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2023|
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
- Toxicity resulting from radiation treatment [ Time Frame: 3.5 years ]Toxicity resulting from radiation treatment will be collected and graded according to the Common Terminology Criteria for Adverse Events, version 4.0
- Cosmesis of the treated breast [ Time Frame: 3.5 years ]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 ]Disease recurrences will be recorded. Any tumor recurrence or death is considered a treatment failure.
- Mastectomy-Free Survival [ Time Frame: 8.5 years ]All surgical interventions will be recorded. Mastectomy and death will be considered treatment failures.
- Overall Survival [ Time Frame: 8.5 years ]Death from any cause is considered a treatment failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212860
|Contact: Muriel Brackstone||519-685-8712||Muriel.Brackstone@lhsc.on.ca|
|London Regional Cancer Program of the Lawson Health Research Institute||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|
|Principal Investigator:||Muriel Brackstone, MD, PhD||Lawson Health Research Institute|