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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification

Outcome Description:

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.

Outcome Time Frame:

Within 1 year of protocol registration

Safety Issue:

Yes

Principal Investigator

Imran Zoberi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

07-1077 / 201106403

NCT ID:

NCT00594477

Start Date:

January 2008

Completion Date:

December 2017

Related Keywords:

  • Breast Cancer
  • IMRT
  • breast cancer with regional nodal metastasis
  • Breast Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110