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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646346
• Other study ID #: 1110009173
• Status: Completed
• Phase: N/A
• Start date: January 10, 2012
• Est. completion date: July 17, 2017

Study information

• Verified date: October 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 17, 2017
• Est. primary completion date: July 17, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Smilow Cancer Hospital Care Center, Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cosmesis by Patient Report	This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.	Within no more than 8 weeks of surgery, but prior to the start of radiation
Secondary	Cosmesis by Patient Report	This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.	1 year post treatment
Secondary	Cosmesis by Patient Report	This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.	3 year post treatment
Secondary	Cosmesis by Medical Doctor Report	Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.	Within no more than 8 weeks of surgery, but prior to the start of radiation
Secondary	Cosmesis by Medical Doctor Report	Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.	1 yr post treatment
Secondary	Cosmesis by Medical Doctor Report	Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.	3 yr post treatment