Stanford APBI Trial
Clinical Trial
Overview
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
OBJECTIVES:
I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI) followed by a 12-week course of maintenance therapy in patients with obsessive compulsive disorder.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Clomipramine
Eligibility
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Primary diagnosis of obsessive compulsive disorder (OCD) for at
least 1 year Meets Diagnostic and Statistical Manual (DSM-IV) criteria by structured
clinical interview Yale-Brown Obsessive-Compulsive Scale (YBOCS) score at least 20 At least
12 if only obsessions or compulsions present Secondary diagnosis of major depression
eligible if: Meets DSM-IV criteria Onset occurs after OCD OCD is primary diagnosis and
dominates clinical picture Excluded diagnoses: Organic mental disorder Principal
psychiatric disorder other than OCD Bipolar disorder Schizophrenia Post-traumatic stress
disorder Tics or Tourette's syndrome Body dysmorphic disorder Delusional disorder
Borderline or schizotypal personality disorder Anorexia nervosa Bulimia nervosa Panic
disorder Panic attacks Must have failed at least 2 prior regimens of serotonin re-uptake
inhibitor therapy --Prior/Concurrent Therapy-- Endocrine therapy: Concurrent thyroid
medication allowed if stable at least 3 months At least 2 weeks since prior systemic
corticosteroids Surgery: No prior psychosurgery or other neurosurgery Other: At least 3
months since prior electroconvulsive or insulin shock therapy At least 6 weeks since prior
fluoxetine At least 30 days since prior investigational drugs At least 2 weeks since any of
the following: Neuroleptics (6 weeks since depot neuroleptics) Nondepot antipsychotics
Anxiolytics Stimulants Barbiturates Antidepressants (4 weeks since monoamine oxidase
inhibitors) At least 2 weeks since prior anticonvulsants No concurrent antipsychotics No
concurrent antihypertensives, e.g., guanethidine or clonidine No concurrent behavior
therapy --Patient Characteristics-- Hematopoietic: No anemia No drug-induced leukopenia No
bleeding disorder No other blood dyscrasia or bone marrow depression Hepatic: Liver
function tests no greater than twice normal No hepatic abnormality Renal: No renal
abnormality, e.g., urinary retention Cardiovascular: No cardiac abnormality, e.g.:
Congestive heart failure Myocardial infarction Cardiac conduction disturbance other than
first-degree heart block Electrocardiogram with significant abnormality No hypertension
Pulmonary: No pulmonary abnormality Other: No hypersensitivity to or prior severe adverse
experience with clomipramine No medical contraindication to serotonin re-uptake inhibitors
or tricyclic antidepressants No history of seizures and not at risk of seizures, i.e.: No
family history of epilepsy No birth trauma No significant head trauma No meningitis or
encephalitis No subarachnoid hemorrhage No episodes of unconsciousness, including syncope
No prostatic hypertrophy No narrow-angle glaucoma, i.e., intraocular pressure greater than
22 mm Hg No uncontrolled hyperthyroidism No other clinically significant abnormality, e.g.:
Neurologic Metabolic Gastrointestinal Autoimmune No substantial risk of suicide At least 6
months since drug or alcohol abuse or dependence No illiteracy No Intelligence Quotient
below 80 No plan for blood donation during study Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.