Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy

(SIGNAL 2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Muriel Brackstone, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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. Eligible participants will be randomized to one of two arms; Arm 1 which is comprised of one neoadjuvant radiation treatment, or Arm 2 which is comprised of three neoadjuvant radiation treatments. The study will also gather information about the safety and effects (good and bad) this radiation has, the immune priming effects of this radiation, and on patient satisfaction with the appearance of the breast.

Research Team

Muriel Brackstone, MD, PhD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

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.

Inclusion Criteria

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

I can undergo surgery within 14-20 days after radiation therapy.

My disease is located in one area.

Exclusion Criteria

I have not had any cancer other than non-melanoma skin cancer in the last 5 years.

I have had treatments other than hormone therapy or radiation for my current breast cancer.

My breast cancer has spread to nearby lymph nodes but hasn't been cleared by biopsy.

Treatment Details

Interventions

• Stereotactic Body Radiation (Radiation Therapy)

Trial Overview 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.

Participant Groups

Group I: Three Fractions Experimental Treatment 1 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 Fraction Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

London Regional Cancer Program of the Lawson Health Research Institute London, Canada

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Patients Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Patients Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Patients Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Patients Recruited

432,000+

Ontario Institute for Cancer Research

Collaborator

Trials

24

Patients Recruited

9,200+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Patients Recruited

1,569,000+

Weill Medical College of Cornell University

Collaborator

Trials

1103

Patients Recruited

1,157,000+