Cyberknife for Early Stage Breast Cancer

NCT03946683 | Completed

• 1 other identifier: 18-01721
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast. Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.

Conditions

Early Stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Local Control Rate

  Mastectomy-free survival rate after Cyberknife body radiosurgery \[Mastectomy and death will be considered failures\]

  1 Year

Secondary Outcomes (3)

• Complication Rate

  1 Year

• Score on The Harvard/NSABP/RTOG Breast Cosmesis Scale.

  Baseline, week 10, and week 26

• Measure of self reported quality of life using the QOLS

  1 Year

Study Arms (1)

Cyberknife for Early Stage Breast Cancer

EXPERIMENTAL

Cyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer.

Radiation: Cyberknife for Early Stage Breast Cancer

Interventions

Cyberknife for Early Stage Breast Cancer RADIATION

Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer

Also known as: SBRT (Stereotactic Body Radiation Therapy)

Cyberknife for Early Stage Breast Cancer

Eligibility Criteria

• Age: 45 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stage 0, I, or II (Tis, Ti, or T2 \<=3cm \& NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion \<= 3 cm, treated with wide excision.
• Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
• Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
• No involved axillary lymph nodes by routine histologic examination (H\&E) of sentinel node(s) or of nodes identified from axillary dissection.
• Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment.

You may not qualify if:

• Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
• Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
• Patients who are pregnant.
• Patients who have any histologically confirmed positive axillary nodes.
• Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Links

• CyberKnife Radiosurgery for Early-Stage Breast Cancer
• University of Texas Southwestern launches clinical trial for treatment of breast cancer using robotic CyberKnife technology

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jonathan A. Haas, MD

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: May 13, 2019
• Study Start: September 1, 2010
• Primary Completion: September 30, 2014
• Study Completion: April 23, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

US (1)