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Intensity Modulated Radiotherapy for Breast Cancer (IMRT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594477
First Posted: January 15, 2008
Last Update Posted: August 10, 2017
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.
Information provided by (Responsible Party):
Washington University School of Medicine
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

    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 ]
  • 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 ]
  • 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 ]
  • Evaluate ipsilateral upper quadrant function [ Time Frame: Pretreatment and 3-4 months following completion of treatment ]
    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 ]
  • Evaluate local-regional control rates [ Time Frame: 12-14 months following completion of radiation therapy ]
  • 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 ]

Enrollment: 100
Actual Study Start Date: January 4, 2008
Study Completion Date: August 8, 2016
Primary Completion Date: August 8, 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00594477


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Imran Zoberi, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Voduc KD, Tyldesley S, Chia S. Risk of radiation pneumonitis in breast cancer patients treated with adjuvant taxanes and radiation. Vol 22; 2004. pp. 624-.
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.
Fayers P AN, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Study Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Brussels: European Organization for Research and Treatment of Cancer; 2001.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00594477     History of Changes
Other Study ID Numbers: 07-1077 / 201106403
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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