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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068263
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : January 4, 2017
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 eligible:

      • 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



  • 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 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


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 therapy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00068263

United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Study Chair: Frank Vicini, MD, FACR William Beaumont Hospital - Royal Oak Campus

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00068263     History of Changes
Other Study ID Numbers: RTOG-0319
First Posted: September 11, 2003    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016

Keywords provided by Radiation Therapy Oncology Group:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases