Clinical trial NCT00594477: Intensity Modulated Radiotherapy for Breast Cancer
Official title: Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: IMRT
breast cancer with regional nodal metastasis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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 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.

Primary outcomes:
measure: Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
timeFrame: Within 1 year of protocol registration
Secondary outcomes:
measure: Evaluate the rate and severity of both acute and late cutaneous toxicity
timeFrame: 6-8 months following completion of treatment and 12-14 months following completion of treatment
measure: Evaluate the rate and severity of late subcutaneous fibrosis
timeFrame: 6-8 months following completion of treatment and 12-14 months following completion of treatment
measure: Evaluate the rate of radiation pneumonitis
timeFrame: 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
measure: Evaluate ipsilateral upper quadrant function
timeFrame: Pretreatment and 3-4 months following completion of treatment
measure: Evaluate patient quality of life
timeFrame: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
measure: Evaluate local-regional control rates
timeFrame: 12-14 months following completion of radiation therapy
measure: Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification
timeFrame: 12-14 months following completion of treatment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Imran Zoberi, MD
role: PRINCIPAL_INVESTIGATOR
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