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.
A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations
There is an unsatisfied medical need for a first-line treatment of lymphatic malformations with a good benefit/risk profile. Based on a patient experience in the institution, the investigators plan to verify whether or not the medication sildenafil has a beneficial effect on lymphatic malformations. The investigators plan to do this by treating patients with lymphatic malformations with the medication sildenafil for a 20 week period. This is an investigator initiated study funded by an Innovations in Patient Care grant and a SPARK grant.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Sildenafil
Eligibility
Inclusion Criteria:
1. Written informed consent(s) for study participation and (where applicable) the use of
the participant's images are obtained according to national regulations from the
participant's parent(s) or guardian(s) prior to performing any study procedures.
2. The participant is 6 months to 10 years of age at inclusion.
3. The participant weight is at least 8kg.
4. A diagnosis of LM or mixed venous lymphatic malformation involving the skin and
subcutaneous tissue and at least 3cm based on clinical and radiographic criteria.
5. LMs may benefit from systemic therapy based on clinical criteria.
6. Females must not be pregnant or breast-feeding.
7. If participant is a child, parent/guardian must be able to follow instructions and
must be willing and able to ensure that the subject is present for all required study
visits.
8. Subject has no contraindication for use of sildenafil.
9. LMs may involve any part of the body.
10. Subject will have normal results on screening tests (eye exam, blood tests).
11. Subject has no contraindication for MRI examinations, such as metal implants, etc.
12. Subject must not be a smoker.
Exclusion Criteria:
1. The participant has a medically unstable health status that may interfere with his/her
ability to complete the study.
2. The participant presents with one or more of the following medical conditions: hepatic
impairment; severe renal impairment; lymphedema conditions such as Milroy disease,
Meige lymphedema, Hennekam syndrome, Njolstad syndrome, Aagenaes syndrome, and Fabry
disease; hypotension or at risk for hypotension; seizures or history of seizures; any
significant cardiovascular risk factors and any condition which requires participants
to use nitric oxide donors or nitrates in any form; underlying anatomic or vascular
risk factors for developing non-arteritic anterior ischemic optic neuropathy (NAION)
including low ocular cup to disc ratio, age over 10, diabetes, hypertension, coronary
artery disease, hyperlipidemia, and smoking. (Participants with Down syndrome, Turner
syndrome, and Noonan syndrome will be considered on a case-by-case basis).
3. The participant has received at least one of the following medications contraindicated
in association with sildenafil within 15 days of inclusion: Alprostadil, Azole
antifungals, Clarithromycins, Conivaptan, Delavirdine, Erythromycins, Fluvoxamine,
Grapefruit, Imatinib, Nefazodone, Nitrates/sodium thiosulfate, Non-selective and
selective alpha blockers, Protease inhibitors, Rufinamide, Tadalafil, Telithromycin,
Vardenafil, Yohimbe, Yohimbine, Amifostine, Lapatinib, Warfarin
4. The participant requires concomitant use of potent cytochrome P450 3A4 inhibitors
(such as ketoconazole, itraconazole, erythromycin, saquinavir) or concomitant use of
ritonavir.
5. The patient has had extensive prior surgery or sclerotherapy to treat LM such that
scarring may interfere with the treatment effect of sildenafil.
6. The participant has previously been administered treatment for LMs or surgical
procedures have been performed to remove the index LMs.
7. Participant is currently pregnant or considering becoming pregnant in the next 20
weeks.
8. The participant is known to have an allergy to sildenafil.
9. Ulcerated or currently infected LMs with pain.
10. Diagnosis of the soft tissue tumor as LM is not clinically certain.
11. The participant is participating in another clinical study.
12. The participant has a history of priapism or is diagnosed with sickle cell anemia or
any other disorder which may predispose to priapism.
13. The investigator may declare any subject ineligible for a valid medical reason.
Ages Eligible for Study
6 Months - 10 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
Andrea Tichy, Ph.D.
650-724-1982
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.