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

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ClinicalTrials.gov Identifier: NCT01162200
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE July 2, 2010
First Posted Date  ICMJE July 14, 2010
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE October 4, 2010
Actual Primary Completion Date July 25, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • Dose-limiting toxicity [ Time Frame: 3 years ]
  • The cosmesis of breast [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer
Official Title  ICMJE A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Stage Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Stereotactic Body Radiation Therapy
SBRT dose per fraction
Intervention: Radiation: Stereotactic Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
75
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
60
Actual Study Completion Date  ICMJE December 28, 2015
Actual Primary Completion Date July 25, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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..
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162200
Other Study ID Numbers  ICMJE STU 072010-015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asal Rahimi, MD UT Southwestern Medical Center Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP