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

NCT01646346 | Completed Results

• 1 other identifier: 1110009173
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Radiation for Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Patients With Reduction in Incidental Radiation

  Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.

  5 day

Secondary Outcomes (6)

• Cosmesis by Patient Report

  Within no more than 8 weeks of surgery, but prior to the start of radiation

• Cosmesis by Patient Report

  1 year post treatment

• Cosmesis by Patient Report

  3 year post treatment

• Cosmesis by Medical Doctor Report

  Within no more than 8 weeks of surgery, but prior to the start of radiation

• Cosmesis by Medical Doctor Report

  1 yr post treatment

Study Arms (1)

4D Conformal Image-Guided Partial Breast RT

EXPERIMENTAL

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

Interventions

4D Conformal Image-Guided Partial Breast RT RADIATION

External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Also known as: 4D conformal image guided radiation therapy

4D Conformal Image-Guided Partial Breast RT

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Smilow Cancer Hospital Care Center, Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Suzanne Evans, MD, MPH
• Organization: Yale University

suzanne.evans@yale.edu

(203) 785-5175

Study Officials

• Suzanne Evans, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2012
• First Posted: July 20, 2012
• Study Start: January 10, 2012
• Primary Completion: July 17, 2017
• Study Completion: July 17, 2017
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-10

Locations

US (1)