Intensity Modulated Radiotherapy for Breast Cancer

Breast Cancer Clinical Trial

— IMRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594477
• Other study ID #: 07-1077 / 201106403
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2008
• Last updated: August 8, 2017
• Start date: January 4, 2008
• Est. completion date: August 8, 2016

Study information

• Verified date: August 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 8, 2016
• Est. primary completion date: August 8, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• IMRT

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (76)

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* Note: There are 76 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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.	Within 1 year of protocol registration
Secondary	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
Secondary	Evaluate the rate and severity of late subcutaneous fibrosis		6-8 months following completion of treatment and 12-14 months following completion of treatment
Secondary	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
Secondary	Evaluate ipsilateral upper quadrant function	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.	Pretreatment and 3-4 months following completion of treatment
Secondary	Evaluate patient quality of life		Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Secondary	Evaluate local-regional control rates		12-14 months following completion of radiation therapy
Secondary	Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification		12-14 months following completion of treatment

External Links

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