Automating Breast Radiation Therapy (RT)

NCT ID: NCT00923871

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2016-04-29

Brief Summary

Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is designed to investigate a method to reduce the time between the planning of radiation treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT) planning process. The investigators plan to examine data from another scan called Cone Beam Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used for treatment). Using these x-ray pictures of patients, the study team consisting of a radiation oncologist, a medical physicist and a radiation therapist will create a custom treatment plan unique to each patient. By doing this, the investigators hope to reduce the amount of time spent waiting for treatment and the number of hospital visits for patients in the future.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cone Beam CT

Group Type: EXPERIMENTAL

Cone Beam CT

Intervention Type: PROCEDURE

Patients will also have a CBCT scan when they are having their first IMRT treatment.

Interventions

Cone Beam CT

Patients will also have a CBCT scan when they are having their first IMRT treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with breast cancer who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
• Patients with any stage of breast cancer.
• Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
• Able to provide a written informed consent.
• 18 years of age or older.

Exclusion Criteria

• < 18 years of age.
• Unable to provide informed consent.
• Males.
• Patients who received partial breast radiation and not the standard dose.
• Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Koch, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Locations

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 09-0197-CE

Identifier Type: -

Identifier Source: org_study_id