4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer

This study is currently recruiting participants.
Verified July 2012 by Yale University
Sponsor:
Information provided by (Responsible Party):
Suzanne Evans, Yale University
ClinicalTrials.gov Identifier:
NCT01646346
First received: March 11, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.


Condition Intervention
Breast Cancer
Radiation: 4D Conformal Image-Guided Partial Breast RT

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction in incidental radiation [ Time Frame: 5 day ] [ Designated as safety issue: No ]
    Reduction in breast radiation V50 less than 45% and V100 less than 23.5%.List instrument or scale


Secondary Outcome Measures:
  • Cosmesis by patient report [ Time Frame: Within no more than 8 weeks of surgery, but prior to the start of radiation ] [ Designated as safety issue: No ]
    patient will be provided with cosmesis scale and self grade cosmesis of breast

  • Cosmesis by patient report [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]
    patient will be provided with cosmesis scale and self grade cosmesis of breast

  • Cosmesis by patient report [ Time Frame: 3 year post treatment ] [ Designated as safety issue: No ]
    patient will be provided with cosmesis scale and self grade cosmesis of breast

  • Cosmesis by medical doctor report [ Time Frame: Within no more than 8 weeks of surgery, but prior to the start of radiation ] [ Designated as safety issue: No ]
    medical doctor will be provided with cosmesis scale and grade cosmesis of breast

  • Cosmesis by medical doctor report [ Time Frame: 1 yr post treatment ] [ Designated as safety issue: No ]
    medical doctor will be provided with cosmesis scale and grade cosmesis of breast

  • Cosmesis by medical doctor report [ Time Frame: 3 yr post treatment ] [ Designated as safety issue: No ]
    medical doctor will be provided with cosmesis scale and grade cosmesis of breast


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4D Conformal Image-Guided Partial Breast RT
This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.
Radiation: 4D Conformal Image-Guided Partial Breast RT
External beam partial breast radiation to target a portion of the breast twice a day for 5 days.
Other Name: 4D conformal image guided radiation therapy

Detailed Description:

This is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4D CT and daily image guidance in Accelerated Partial Breast Irradiation (APBI) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose. The two specific breasts constraints which shall be decreased are the V50 (percent volume of breast receiving 50% of the prescribed dose) and the V100 (percent volume of breast receiving 100% of the prescribed dose). The goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the NSABP B39 standard of 60% and 35%.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
  • Patient must be > 50 years old.
  • The patient should have a life expectancy of at least two years with a karnofsky performance status > 70.
  • The patient must have stage 0 or I breast cancer.
  • On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
  • Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
  • Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.)
  • Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS.
  • The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
  • Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Chemotherapy is permitted if planned for ≥ 2 weeks after radiation.
  • Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy.
  • Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed.
  • The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less.

Exclusion Criteria:

  • Men are not eligible for this study as men are not breast conservation candidates.
  • T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.
  • Any positive axillary nodes.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
  • Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.
  • Paget's disease of the nipple.
  • History of invasive breast cancer or DCIS in the same breast.
  • Surgical margins that cannot be microscopically assessed or are less then 2 mm.
  • Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
  • Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.
  • Patients with coexisting medical conditions in whom life expectancy is < 2 years.
  • Patients with skin involvement, regardless of tumor size.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646346

Contacts
Contact: Jeannie Kluytenaar, RN 203-785-2368 jeannie.kluytenaar@yale.edu
Contact: Anne McKeon, BS 203-737-2587 anne.mckeon@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Suzanne Evans, MD Yale University
Principal Investigator: Joanne Weidhaas, MD Yale University
  More Information

No publications provided

Responsible Party: Suzanne Evans, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01646346     History of Changes
Other Study ID Numbers: 1110009173
Study First Received: March 11, 2012
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Breast Cancer
Radiation for Breast Cancer

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

ClinicalTrials.gov processed this record on April 17, 2014