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Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study


Phase 1
55 Years
80 Years
Open (Enrolling by invite only)
Female
Breast Cancer

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Trial Information

Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study


This study will assess the safety of partial breast radiosurgery as measured by the
incidence of acute toxicity and wound healing complications in three dose cohorts.

Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2
or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be
stopped for evaluation and consideration of revision. If at most one DLT is observed then
escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of
irradiation.


Inclusion Criteria:



- Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in
situ or invasive ductal (or other favorable histology) carcinoma of the breast

- Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging
evidence of multicentric or multifocal disease, no pregnant women, and no comorbid
conditions precluding surgery)

- Clinical T1N0M0

- 55 years of age or older

- Estrogen receptor (ER) positive,

- No evidence of lymphovascular space invasion on initial biopsy

- Not pregnant. If not post-menopausal must adhere to birth control measures

- White blood cell count > 3000, Hemoglobin > 9, platelets >100000

- Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

Exclusion Criteria:

- Neoadjuvant chemotherapy

- Breast implants

- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus,
rheumatoid arthritis, scleroderma)

- Patients unable to receive study treatment planning secondary to body habitus or
inability to lie flat on the stomach at length

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

as measured by the incidence of acute toxicity and wound healing complications

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Janet Horton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Dept of Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

Pro00015617

NCT ID:

NCT00944528

Start Date:

January 2010

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Cancer of Breast
  • Cancer of the Breast
  • Neoplasms, Breast
  • Single dose radiation
  • Radiotherapy
  • Preoperative
  • Breast Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710