Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation

NCT02272400 | Completed DMC

• 1 other identifier: 07-582
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

image guided radiation therapy; partial breast irradiation; breast cancer; breast; cancer; breast preservation; IGRT; PBI

Outcome Measures

Primary Outcomes (1)

• Measure the outcome of applying IGRT to PBI

  Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting. Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field

  10 years

Secondary Outcomes (2)

• Feasibility of accelerated dose fractionation

  1 - 10 years

• Genetic pre-disposition of patient to post-treatment radiation fibrosis

  1 - 10 years

Study Arms (1)

IGRT of prone partial breast

EXPERIMENTAL

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.

Other: IGRT for prone partial breast irradiation (PBI)

Interventions

IGRT for prone partial breast irradiation (PBI) 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.

Also known as: IGRT, PBI

IGRT of prone partial breast

Eligibility Criteria

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

You may qualify if:

• Post-menopausal women defined as either:
• at least 2 years without menstrual period or
• patients older than 50 with serological evidence of post-menopausal status or
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Laura and Isaac Perlmutter Cancer Center at NYU

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Carmen Perez, M.D.

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 23, 2014
• Study Start: August 7, 2007
• Primary Completion: October 29, 2014
• Study Completion: October 29, 2014
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)