Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI RTOG-0319 NCT00068263, RTOG-0319

Objectives

1. 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.
2. Determine the cosmetic results in patients treated with this regimen.
3. Determine the complication rates in patients treated with this regimen.
4. Determine the local control rate in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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 (DCIS)



• 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 cancer



• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• At least 2 weeks since prior chemotherapy
• No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy

Endocrine therapy

• Concurrent anastrozole or tamoxifen allowed

Radiotherapy

• No prior radiotherapy for the current malignancy

Surgery

• See Disease Characteristics

Other

• No prior nonhormonal therapy for the current malignancy

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 2 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• 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 dermatomyositis)
• 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

Expected Enrollment

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

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.

Vicini F, Winter K, Straube W, et al.: A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for Stage I/II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) Study 0319. Int J Radiat Oncol Biol Phys 63 (5): 1531-7, 2005.[PUBMED Abstract]

Vicini F, Winter K, Straube W, et al.: 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/ II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) study 0319. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-4067, 2004.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Frank Vicini, MD, FACR, Protocol chair		Ph: 248-551-1219; 800-633-7377

Registry Information
Official Title		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
Trial Start Date		2003-08-15
Registered in ClinicalTrials.gov		NCT00068263
Date Submitted to PDQ		2003-06-18
Information Last Verified		2004-10-18
NCI Grant/Contract Number		CA21661

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