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A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma


- Determine the technical feasibility and reproducibility of three-dimensional conformal
radiotherapy confined to the region of the lumpectomy cavity in women with stage I or
II breast cancer.

- Determine the cosmetic results in patients treated with this regimen.

- Determine the complication rates in patients treated with this regimen.

- Determine the local control rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning
within 8 weeks after surgery.

Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year,
every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to
15.3 months.

Inclusion Criteria


- Histologically confirmed invasive breast cancer

- Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1)

- Unifocal disease (single focus that can be encompassed by one lumpectomy)

- The following histologies are eligilble:

- Invasive ductal

- Medullary

- Papillary

- Colloid (mucinous)

- Tubular

- No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ

- No nonepithelial breast malignancies such as sarcoma or lymphoma

- Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary
dissection of at least 6 lymph nodes or a sentinel node biopsy

- Six surgical clips in place delineating the margins of the tylectomy cavity

- Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR
re-excision specimen available for confirmation

- Negative mammography post-lumpectomy or post-excision if malignancy-associated
microcalcifications were initially present

- No prior lumpectomy so extensive that the cosmetic result is low or poor prior
to radiotherapy

- No more than 3 positive axillary nodes

- No proven multicentric carcinoma (tumors in different quadrants of the breast or
tumor separated by at least 4 cm) with other clinically or radiographically
suspicious areas in the ipsilateral breast unless negative by biopsy

- No palpable or radiographically suspicious contralateral axillary, supraclavicular,
infraclavicular, or internal mammary nodes unless nodes are histologically negative

- No extensive intraductal carcinoma, indicated by one of the following according to
the Harvard definition:

- More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue

- Intraductal carcinoma with microinvasion

- No previously treated contralateral breast cancer or synchronous ipsilateral breast

- No evidence of suspicious microcalcifications

- No Paget's disease of the nipple

- No skin involvement by disease, regardless of tumor size

- No distant metastases

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- At least 2 years


- Not specified


- Not specified


- Not specified


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Technically suitable for breast radiotherapy

- No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or

- No other medical condition that would limit life expectancy

- No psychiatric or addictive disorders that would preclude giving informed consent

- No other malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy

- Not specified


- At least 2 weeks since prior chemotherapy

- No concurrent chemotherapy during and for at least 2 weeks after completion of study

Endocrine therapy

- Concurrent anastrozole or tamoxifen allowed


- No prior radiotherapy for the current malignancy


- See Disease Characteristics


- No prior nonhormonal therapy for the current malignancy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Frank Vicini, MD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

William Beaumont Hospital - Royal Oak Campus


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms



Foundation for Cancer Research and Education Phoenix, Arizona  85013
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449