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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00068263
First received: September 10, 2003
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: August 2003
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068263

Locations
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
Investigators
Study Chair: Frank Vicini, MD, FACR William Beaumont Hospital - Royal Oak Campus
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00068263     History of Changes
Other Study ID Numbers: RTOG-0319, CDR0000316246
Study First Received: September 10, 2003
Last Updated: August 9, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 17, 2014