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

December 30, 2016 updated by: Radiation Therapy Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)
NRG Oncology

Investigators

  • Study Chair: Frank Vicini, MD, FACR, William Beaumont Hospital - Royal Oak Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 10, 2003

First Submitted That Met QC Criteria

September 10, 2003

First Posted (Estimate)

September 11, 2003

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-0319
  • CDR0000316246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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