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Completed

NCT Number: NCT00594477

Intensity Modulated Radiotherapy for Breast Cancer

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMRT

Radiation

Primary outcomes

  1. 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:

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. Evaluate patient quality of life

    Time frame: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment

  6. Evaluate local-regional control rates

    Time frame: 12-14 months following completion of radiation therapy

  7. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study

Acronym: IMRT

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2008
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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