Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment igrt for prone partial breast irradiation (pbi)
Phase phase 1/phase 2
Sponsor New York University School of Medicine
Start date September 2007
End date September 2019
Trial size 310 participants
Trial identifier NCT02272400, S07-582

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
igrt for prone partial breast irradiation (pbi) IGRT
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.

Primary Outcomes

Measure
Measure the outcome of applying IGRT to PBI
time frame: 10 years

Secondary Outcomes

Measure
Feasibility of accelerated dose fractionation
time frame: 1 - 10 years
Genetic pre-disposition of patient to post-treatment radiation fibrosis
time frame: 1 - 10 years

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
Principal investigator Silvia C Formenti, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.