Intensity Modulated Radiotherapy for Breast Cancer

NCT00594477 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 07-1077 / 201106403
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

IMRT; breast cancer with regional nodal metastasis

Outcome Measures

Primary Outcomes (1)

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

  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.

  Within 1 year of protocol registration

Secondary Outcomes (7)

• Evaluate the rate and severity of both acute and late cutaneous toxicity

  6-8 months following completion of treatment and 12-14 months following completion of treatment

• Evaluate the rate and severity of late subcutaneous fibrosis

  6-8 months following completion of treatment and 12-14 months following completion of treatment

• Evaluate the rate of radiation pneumonitis

  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

  Pretreatment and 3-4 months following completion of treatment

• Evaluate patient quality of life

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

Study Arms (1)

IMRT

EXPERIMENTAL

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

Interventions

IMRT RADIATION

IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (76)

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Imran Zoberi, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: January 4, 2008
• Primary Completion: August 8, 2016
• Study Completion: August 8, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)