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Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162200
First Posted: July 14, 2010
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.

Condition Intervention Phase
Early Stage Breast Cancer Radiation: Stereotactic Body Radiation Therapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The maximum tolerated dose to the lumpectomy cavity in patients with early stage breast cancer [ Time Frame: 3 years ]
    To escalate the dose of stereotactic radiotherapy utilizing the Cyberknife system to a tumorcidal dose to the lumpectomy cavity without exceeding the maximum tolerated dose in patients with early stage breast cancer.


Secondary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: 3 years ]
  • The cosmesis of breast [ Time Frame: 3 years ]

Estimated Enrollment: 75
Actual Study Start Date: October 4, 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stereotactic Body Radiation Therapy
SBRT dose per fraction
Radiation: Stereotactic Body Radiation Therapy
3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation).
Other Name: SBRT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DCIS or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologies.
  • Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 or T2 (≤3 cm) treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy. Patients with up to 3 positive nodes without microscopic or macroscopic evidence of extracapsular extension are eligible.
  • The patient's Zubrod performance status must be 0-2.
  • Patients must be ≥ 18 years of age.
  • If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation therapy.
  • Unifocal breast cancer (no evidence of gross multifocal disease, multicentric, or bilateral disease.
  • Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as >2 mm clear of tumor in all directions).
  • Negative post- lumpectomy mammography if malignancy-associated microcalcifications were initially present.
  • The target lumpectomy cavity must be clearly delineated.
  • Patients must complete appropriate pretreatment evaluation, including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal.

Exclusion Criteria:

  • Evidence of suspicious microcalcifications in the breast prior to start of radiation.
  • Patients with history of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
  • Patients with 4 or more histologically positive axillary nodes if axillary dissection is performed.
  • Patients with distant metastases.
  • Patients with invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy.
  • Patients must not have any palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
  • Any previously treated contralateral invasive breast carcinoma or synchronous contralateral breast carcinoma.
  • Prior non-hormonal therapy or radiation therapy for the current breast cancer or hormonal therapy for > 28 days after diagnosis or refusal to discontinue hormonal therapy.
  • Patients with Paget's disease of the nipple
  • Patients with prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • Patients with severe, active co-morbidity.
  • Patients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consent.
  • Patients who are pregnant or lactating.
  • Previous breast radiation on either side or thoracic radiation on the ipsilateral side..
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01162200


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Asal Rahimi, MD UT Southwestern Medical Center Dallas
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01162200     History of Changes
Other Study ID Numbers: STU 072010-015
First Submitted: July 2, 2010
First Posted: July 14, 2010
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases