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Radiation Therapy

Stereotactic Body Radiation Then Surgery for Breast Cancer (SIGNAL 2 Trial)

N/A

Waitlist Available

Led By Muriel Brackstone, MD, PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical expectation that a > 2mm margin can be obtained

Unicentric/unifocal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8.5 years

Awards & highlights

SIGNAL 2 Trial Summary

This trial will help determine if a shorter, more targeted radiation therapy can be just as effective as the current standard treatment for breast cancer.

Who is the study for?

This trial is for postmenopausal women over 50 with certain types of early-stage breast cancer (like invasive ductal carcinoma) that hasn't spread. They should be able to undergo surgery within 14-20 days after radiation and lie in a specific position during treatment. Women who've had previous radiation to the same breast, have widespread cancer, or can't commit to the study's requirements are not eligible.Check my eligibility

What is being tested?

The trial tests if targeted radiation therapy before lumpectomy (breast-conserving surgery) can prevent cancer recurrence and replace standard lengthy post-surgery radiation. Participants will receive either one or three sessions of focused pre-surgery radiation to see which is more effective.See study design

What are the potential side effects?

Potential side effects may include skin changes at the treated area, fatigue, discomfort from lying still in a prone position during treatment, and typical surgical risks like infection or poor wound healing.

SIGNAL 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery aims to remove the tumor with a margin of more than 2mm.

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My disease is located in one area.

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My cancer is at least 1 cm away from the skin surface.

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My lymph nodes do not show cancer signs based on exams.

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I am 50 years or older and have gone through menopause.

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My tumor is smaller than 3cm, based on scans.

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My breast cancer is of a type that tends to respond well to treatment.

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My cancer is positive for estrogen receptors.

SIGNAL 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Angiogenesis will be measured

Apoptosis markers will be measured

Tumor Markers

+4 more

Secondary outcome measures

Cosmesis of the treated breast

Disease

Mastectomy

+1 more

SIGNAL 2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Three FractionsExperimental Treatment1 Intervention

Stereotactic neoadjuvant ablative radiation give in three doses of 10 Gy (30 Gy given in 3 fractions, one treatment every second business day). Lumpectomy to follow within 14-20 days from last radiation treatment.

Group II: Single FractionExperimental Treatment1 Intervention

Stereotactic neoadjuvant ablative radiation give in one single dose of 21 Gy. Lumpectomy to follow within 14-20 from radiation treatment date.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ontario Institute for Cancer ResearchOTHER

23 Previous Clinical Trials

9,046 Total Patients Enrolled

6 Trials studying Breast Cancer

732 Patients Enrolled for Breast Cancer

Sunnybrook Health Sciences CentreOTHER

656 Previous Clinical Trials

1,551,169 Total Patients Enrolled

30 Trials studying Breast Cancer

16,896 Patients Enrolled for Breast Cancer

Weill Medical College of Cornell UniversityOTHER

1,055 Previous Clinical Trials

1,316,156 Total Patients Enrolled

30 Trials studying Breast Cancer

27,182 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a current opportunity to enroll in this medical experiment?

"Clinicaltrials.gov reveals that the recruitment phase of this trial has already been completed, as its last edit was on May 13th 2022. While no longer actively recruiting participants, there are currently 4,570 other studies with open enrolment opportunities."

Answered by AI

What is the ultimate goal of this medical research project?

"This 1.5-year trial will monitor patients for any adverse effects arising from radiation therapy. Secondary objectives include tracking Disease-Free Survival, Overall Survival and the aesthetic results of treatment (as judged by patient, surgeon and radiologist via Modified Harvard-Harris Cosmetic Scale). If a tumor recurrence or death occurs during this time period it is considered a failed attempt at treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy

Muriel Brackstone 2015. "Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02212860.