Trial record 3 of 4 for:    NSABP B39 BREAST

Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02272400
First received: October 8, 2014
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.


Condition Intervention Phase
Breast Cancer
Radiation: IGRT for prone partial breast irradiation (PBI)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Measure the outcome of applying IGRT to PBI [ Time Frame: 10 years ] [ Designated as safety issue: No ]

    Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting.

    Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field



Secondary Outcome Measures:
  • Feasibility of accelerated dose fractionation [ Time Frame: 1 - 10 years ] [ Designated as safety issue: No ]
    Assess the feasibility of an accelerated dose fractionation (600 cGy x 5) when given over five consecutive day by measuring the acute and late radiation toxicity

  • Genetic pre-disposition of patient to post-treatment radiation fibrosis [ Time Frame: 1 - 10 years ] [ Designated as safety issue: No ]
    Prospectively determine if genetic factors can be identified which may predispose a patient to the development of post-treatment radiation fibrosis


Estimated Enrollment: 312
Study Start Date: September 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGRT of prone partial breast
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy.
Radiation: IGRT for prone partial breast irradiation (PBI)
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.
Other Names:
  • IGRT
  • PBI

Detailed Description:

Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women defined as either:

    1. at least 2 years without menstrual period or
    2. patients older than 50 with serological evidence of post-menopausal status or
    3. hysterectomized patients of any age with FSH confirmation of post-menopausal status
  • pT1 breast cancer, excised with negative margins
  • pN0 or sentinel node negative or N0 clinically if the tumor is < 1 cm in size

Exclusion Criteria:

  • Previous radiation therapy to the ipsilateral breast
  • Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
  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: NCT02272400

Contacts
Contact: Silvia C Formenti, M.D. (212) 731-5039 silvia.formenti@ynumc.org
Contact: Ravi Kathirithamby, MBA (212) 731-5335 ravindran.kathirithamby@nyumc.org

Locations
United States, New York
Laura and Isaac Perlmutter Cancer Center at NYU Recruiting
New York, New York, United States, 10016
Contact: Silvia C Formenti, M.D.    212-731-5039    silvia.formenti@nyumc.org   
Contact: Ravi Kathirithamby, MBA    (212) 731-5335    ravindran.kathirithamby@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Silvia C Formenti, M.D. NYU Langone Medical Center
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02272400     History of Changes
Other Study ID Numbers: S07-582
Study First Received: October 8, 2014
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
image guided radiation therapy
partial breast irradiation
breast cancer
breast
cancer
breast preservation
IGRT
PBI

ClinicalTrials.gov processed this record on March 26, 2015