Intraoperative Radiation Therapy in Preventing Breast Cancer Recurrence in Patients with Ductal Carcinoma in Situ

Status: Active

Description

This phase II trial studies how well intraoperative radiation therapy works in preventing breast cancer recurrence in patients with ductal carcinoma in situ. Intraoperative radiation therapy is given one time in the operating room, directly to the site from where the tumor was removed. It may prevent the ductal carcinoma in situ from returning and may cause minimal or no damage to normal tissue and organs.

Eligibility Criteria

Inclusion Criteria

  • Pathologically confirmed DCIS of the breast
  • Clinical =< 2.0 cm unifocal lesion
  • No clinical or pathologic evidence of nodal involvement
  • Operable DCIS, suitable for breast conserving surgery
  • Plans to administer irradiation to the breast only
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist
  • Must have had a diagnostic mammogram performed within the last 6 months
  • Appropriate renal, liver, and hematologic lab values
  • Women of child-bearing potential must have a negative pregnancy test within 1 week of IORT treatment
  • Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative of the negative pregnancy test through the radiation treatment period
  • English or Spanish speaking
  • Able to sign informed consent
  • Amenable to regular follow-up (according to research policies) for at least 5 years

Exclusion Criteria

  • Histologic or clinical evidence of invasive breast cancer
  • Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
  • Synchronous bilateral breast cancer at the time of diagnosis
  • Pathologic or imaging evidence of lymph node involvement
  • Patients with any severe concomitant disease that may limit their life expectancy to less than 5 years
  • Prior history of breast cancer or in-field radiation in the ipsilateral breast
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IORT

Locations & Contacts

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Eileen Patricia Connolly
Phone: 212-305-5050
Email: epc2116@cumc.columbia.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the rates of local recurrence as defined by ipsilateral breast tumor recurrence at 5 years in patients with low-intermediate and high-grade ductal carcinoma in situ (DCIS) following treatment with intraoperative radiotherapy (IORT).

SECONDARY OBJECTIVES:

I. To determine relapse-free survival in women with DCIS following breast conserving surgery (BCS) and IORT at 5 years.

II. To determine overall survival in women with DCIS following BCS and IORT at 5 years.

III. To identify and quantify the frequency of any grade >= 2 acute (=< 6 month) and long-term radiation toxicity following IORT.

IV. To evaluate acute (=< 6 month) and long-term cosmetic outcomes following IORT.

V. To determine acute and long-term physician-reported toxicity burden.

VI. To determine acute and long-term patient-reported outcomes of cosmesis, quality of life, breast symptoms, and toxicity burden following IORT.

VII. To identify and quantify the rates of mammographic changes following IORT.

VIII. To determine the rates of additional follow-up imaging and biopsies performed for mammographic changes.

TERTIARY OBJECTIVES:

I. To evaluate predictors (patient, treatment, and tumor-related) of short-term and long-term outcomes.

II. To determine the level of agreement between provider and patient-reported assessments of toxicity, cosmesis, quality of life, and toxicity burden following IORT.

III. To explore the correlation of blood-based, breast tumor microenvironment, and other potential predictive biomarkers with response to IORT.

IV. To investigate the use of Rapid Automated Biodosimetry Technology (RABiT) to evaluate predictors of radiosensitivity.

OUTLINE:

Patients undergo breast conserving surgery and immediately undergo intraoperative radiation therapy over 15-40 minutes.

After completion of study treatment, patients are followed up within 2-6 weeks, at 6 months, then yearly for 5 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center

Principal Investigator
Eileen Patricia Connolly

Trial IDs

Primary ID AAAQ7853
Secondary IDs NCI-2017-01652
Clinicaltrials.gov ID NCT03216421