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Pilot study of Image Guided RT for Stage 0 and 1 Breast Study

Conditions

Breast - Female | Breast Cancer

Trial Phase

Phase Pilot

Trial Purpose and Description

Trial Purpose

4 Dimensional (4D) Conformal Partial Breast Radiation Treatment plan. 4DCRT to 38.5Gy in 3.85 fractions delivered BID with daily image guidance and a minimum six hours between fractions.


Participation Guidelines

Age:
50 Years and older
Gender:
Female

Eligibility Criteria

Eligibility Criteria

4.1 Inclusion Criteria

Women who satisfy all of the following conditions are the only patients who will be eligible for this study.

1. The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.

2. Patient must be > 50 years old.

3. The patient should have a life expectancy of at least two years with a karnofsky performance status >70.

4. The patient must have stage 0 or I breast cancer.

5. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.

6. 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.

7. 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.)

8. 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.

9. 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).

10. Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. 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.

11. Chemotherapy is permitted if planned for &ge 2 weeks after radiation.

12. 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.

13. 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.

14. 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.

4.2 Exclusion Criteria

1. Men are not eligible for this study as men are not breast conservation candidates.

2. T0, T2 (>2.0 cm), T3, node positive, stage III or IV breast cancer.

3. Any positive axillary nodes.

4. Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.

5. Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.

6. Non-epithelial breast malignancies such as sarcoma or lymphoma.

7. Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.

8. Paget&rsquos disease of the nipple.

9. History of invasive breast cancer or DCIS in the same breast.

10. Surgical margins that cannot be microscopically assessed or are less then 2 mm.

11. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.

12. 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.

13. Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.

14. Patients with coexisting medical conditions in whom life expectancy is < 2 years.

15. Patients with skin involvement, regardless of tumor size.

16. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible.

Sponsor:
Yale Cancer Center
Dates:
01/10/2012
Last Updated:
Study HIC#:
1110009173