Intensity Modulated Radiotherapy for Breast Cancer (IMRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00594477
First received: January 4, 2008
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast. These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).


Condition Intervention Phase
Breast Cancer
Radiation: IMRT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification [ Time Frame: Within 1 year of protocol registration ] [ Designated as safety issue: Yes ]

    The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes:

    1. Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
    2. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales.
    3. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence.
    4. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.


Secondary Outcome Measures:
  • Evaluate the rate and severity of both acute and late cutaneous toxicity [ Time Frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment ] [ Designated as safety issue: Yes ]
  • Evaluate the rate and severity of late subcutaneous fibrosis [ Time Frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment ] [ Designated as safety issue: Yes ]
  • Evaluate the rate of radiation pneumonitis [ Time Frame: 6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment ] [ Designated as safety issue: Yes ]
  • Evaluate ipsilateral upper quadrant function [ Time Frame: Pretreatment and 3-4 months following completion of treatment ] [ Designated as safety issue: No ]
    For patients who receive physical therapy, objective measures of the rotator cuff, bursa, and joint space will be evaluated by diagnostic ultrasound if medically indicated.

  • Evaluate patient quality of life [ Time Frame: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment ] [ Designated as safety issue: No ]
  • Evaluate local-regional control rates [ Time Frame: 12-14 months following completion of radiation therapy ] [ Designated as safety issue: No ]
  • Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification [ Time Frame: 12-14 months following completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT
The prescribed dose for all patients will be 5040 cGy in 28 fractions. Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.
Radiation: IMRT

Detailed Description:

IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs) and nearby normal tissue.

  Eligibility

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

Inclusion Criteria:

  • Female gender
  • Age ≥ 18 years
  • Invasive primary female breast cancer
  • Pathologically proven regional nodal metastasis
  • Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
  • Signed study specific consent form

Exclusion Criteria:

  • Distant metastasis
  • Currently Pregnant
  • Psychiatric or addictive disorders that preclude informed consent
  • Time from initial diagnosis to the start of radiation therapy > one year
  • Estimated life expectancy judged to be < one year
  • Prior radiation to the ipsilateral breast or chest wall
  • Primary breast cancer is lymphoma or sarcoma
  • Patients being treated with concurrent chemotherapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594477

Contacts
Contact: Imran Zoberi, MD (314) 362-8525 zoberi@radonc.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Imran Zoberi, M.D.         
Sub-Investigator: Sreekrishna Goddu, Ph.D.         
Sub-Investigator: Michael Naughton, M.D.         
Sub-Investigator: Julie Margenthaler, M.D.         
Sub-Investigator: Heidi Prather, D.O.         
Sub-Investigator: Renee Ivens, P.T., D.P.T.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Imran Zoberi, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Pierce LJ, Butler JB, Martel MK, et al. Postmastectomy radiotherapy of the chest wall: dosimetric comparison of common techniques. Int J Radiat Oncol Biol Phys 2002;52:1220-1230.
Emami B, Lyman J, Brown A, et al. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys 1991;21:109-122.
Marks LB, Yu X, Prosnitz RG, et al. The incidence and functional consequences of RT-associated cardiac perfusion defects. Int J Radiat Oncol Biol Phys 2005;63:214-223.
Lind PA, Marks LB, Hardenbergh PH, et al. Technical factors associated with radiation pneumonitis after local +/- regional radiation therapy for breast cancer. Int J Radiat Oncol Biol Phys 2002;52:137-143
Jaen J, Vazquez G, Alonso E, et al. Changes in pulmonary function after incidental lung irradiation for breast cancer: A prospective study. Int J Radiat Oncol Biol Phys 2006;65:1381-1388.
Fan M, Marks LB, Lind P, et al. Relating radiation-induced regional lung injury to changes in pulmonary function tests. Int J Radiat Oncol Biol Phys 2001;51:311-317.
Stoll B, Andrews J. Radiation-induced peripheral neuropathy. British Medical Journal 1996;1:837-843.
Thompson AM, Air M, Jack WJL, et al. Arm morbidity after breast conservation and axillary therapy. The Breast 1995;4:273-276.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00594477     History of Changes
Other Study ID Numbers: 07-1077 / 201106403
Study First Received: January 4, 2008
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
IMRT
breast cancer with regional nodal metastasis

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

ClinicalTrials.gov processed this record on July 28, 2014