Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
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.
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Erlotinib
Eligibility
Inclusion Criteria:
- Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
- Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition
staging criteria
- Patients must have undergone surgical resection with curative intent within 6 months
of enrollment
- Sufficient tumor tissue available for EGFR mutation analysis
- At least ONE of the following patient characteristics: previously detected deletion 19
or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim
ethnicity (to be enrolled in the screening portion of trial).
- 18 years of age or older
- Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point
mutation
- ECOG Performance status of 0,1, or 2
- Adequate organ function as outlined in protocol
Exclusion Criteria:
- Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
- Confirmed T790M resistance mutation in the primary tumor sample
- Prior exposure to EGFR tyrosine kinase inhibitors
- Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
- Pregnant or breastfeeding women
- Any evidence of clinically active interstitial lung disease
- Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine,
oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the study
- Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto
the trial, or failure to recover from the side effects of any of these agents
Ages Eligible for Study
18 Years - N/A
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
Cancer Clinical Trials Office
650-498-7061
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.