Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation

NCT ID: NCT02272400

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-07
• Study Completion Date: 2014-10-29

Brief Summary

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.

Detailed Description

Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).

Conditions

Breast Cancer

Study Design

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

Study Groups

IGRT of prone partial breast

IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy.

Group Type: EXPERIMENTAL

IGRT for prone partial breast irradiation (PBI)

Intervention Type: OTHER

IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.

Interventions

IGRT for prone partial breast irradiation (PBI)

IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.

Intervention Type: OTHER

Other Intervention Names

IGRT; PBI

Eligibility Criteria

Inclusion Criteria

• Post-menopausal women defined as either:

1. at least 2 years without menstrual period or

2. patients older than 50 with serological evidence of post-menopausal status or

3. hysterectomized patients of any age with FSH confirmation of post-menopausal status

• pT1 breast cancer, excised with negative margins
• pN0 or sentinel node negative or N0 clinically if the tumor is < 1 cm in size

Exclusion Criteria

• Previous radiation therapy to the ipsilateral breast
• Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Perez, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

Laura and Isaac Perlmutter Cancer Center at NYU

New York, New York, United States

Countries

United States

Other Identifiers

07-582

Identifier Type: -

Identifier Source: org_study_id