Clinical trial NCT01570998: Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
Official title: Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stage IA Breast Cancer
Stage IIA Breast Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec AG
First posted: 2012-04-04
Enrollment: 1259
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE:

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

Eligibility criteria: Inclusion Criteria:

* Suitable for breast conserving surgery
* T1 and T2 (\< 3.5 cm), N0, M0

Exclusion Criteria:

* Axillary lymph node positive breast cancer
* Tumor size \> 3.5 cm
* Extensive intraductal component (EIC \>= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
* Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
* Inability to assess pathologic margin status
* Synchronous bilateral breast cancer at the time of diagnosis
* Ipsilateral breast had a previous cancer and/or prior in-field radiation
* Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
* Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
* Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
* Any factor included as exclusion criteria in the participating center's treatment policy statement
* Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):

  * Patients under the age of 50
  * Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
  * Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
  * Lymphovascular invasion
  * High grade
  * Tumors \> 3 cm
  * Node positive patients
  * Prior chemotherapy or hormone therapy

Primary outcomes:
measure: Incidence of local recurrence
timeFrame: Up to 5 years
measure: Frequency of site of relapse within the breast
timeFrame: Up to 5 years
measure: Percentage of participants with treatment-related adverse events
timeFrame: Up to 5 years
measure: Median Relapse-free survival
timeFrame: Up to 5 years
measure: Median Overall Survival
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center-Herrick Campus
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: Dignity Health - California Hospital Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center-Walnut Creek
state: California
city: Greenwich
country: United States
facility: Greenwich Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Cleveland Clinic
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Community Cancer Center South
state: Indiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Saint Joseph
country: United States
facility: Marie Yeager Cancer Center, Spectrum Health Lakeland
state: Michigan
city: Dobbs Ferry
country: United States
facility: Community Hospital at Dobbs Ferry
state: New York
city: Ithaca
country: United States
facility: Cornell University
state: New York
city: New York
country: United States
facility: Columbia University/Herbert Irving Cancer Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Easton
country: United States
facility: Saint Luke's Hospital-Anderson Campus
state: Pennsylvania
city: Fairfax
country: United States
facility: Inova Fairfax Hospital Cancer Center
state: Virginia
city: Newport News
country: United States
facility: Sentara Port Warwick
state: Virginia
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: University of California, San Francisco
name: Michael Alvarado, MD
role: PRINCIPAL_INVESTIGATOR
References: