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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01162200
First received: July 2, 2010
Last updated: May 19, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • The cosmesis of breast [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162200

Contacts
Contact: Robert Timmerman, MD 214-645-8525

Locations
United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Robert Timmerman, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Jean Wu, MSN    214-645-8525      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert Timmerman, MD UT Southwestern Medical Center Dallas
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01162200     History of Changes
Other Study ID Numbers: SCCC-02110
Study First Received: July 2, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014