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.
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Computed Tomography (CT)
- drug: Imaging Agent
- procedure: Neck Dissection
- procedure: Planar Imaging
- procedure: Sentinel Lymph Node Biopsy
- procedure: Single Photon Emission Computed Tomography
Eligibility
Inclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION INCLUSION:
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell
carcinoma of the oral cavity, including the oral (mobile) tongue, floor of mouth
(FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge,
retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration
- Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC]
8th edition [ed.]) based on the following diagnostic workup:
- History/physical examination within 42 days prior to registration
- Imaging of head and neck within 42 days prior to registration
- PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic
resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic
quality CT is preferred and highly recommended for the PET/CT when possible.
- Imaging of chest within 42 days prior to registration; chest x-ray, CT chest
scan (with or without contrast) or PET/CT (with or without contrast)
- Surgical assessment within 42 days prior to registration. Patient must be a candidate
for surgical intervention with sentinel lymph node (SLN) biopsy and potential
completion neck dissection (CND) or elective neck dissection (END)
- Surgical resection of the primary tumor will occur through a transoral approach
with anticipation of resection free margins
- Zubrod performance status 0-2 within 42 days prior to registration
- For women of child-bearing potential, negative serum or urine pregnancy test within 42
days prior to registration
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry
- Only patients who are able to read and understand English are eligible to participate
as the mandatory patient reported NDII tool is only available in this language
- PRIOR TO STEP 2 RANDOMIZATION:
- FDG PET/CT required prior to step 2. Note: FDG PET/CT done prior to step 1 can be
submitted for central review.
- PET/CT node negative patients, determined by central read, will proceed to
randomization.
- PET/CT node positive patients will go off study, but will be entered in a
registry and data will be collected to record the pathological outcome of neck
nodes for diagnostic imaging assessment and future clinical trial development
- NOTE: All FDG PET/CT scans must be performed on an American College of
Radiology (ACR) accredited scanner (or similar accrediting organization)
- The patient must complete NDII prior to step 2 registration
Exclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION EXCLUSION:
- Definitive clinical or radiologic evidence of regional (cervical) and/or distant
metastatic disease
- Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer,
including effectively treated basal cell or squamous cell skin cancer, or carcinoma in
situ of the breast or cervix) unless disease free for ≥ 2 years
- Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx,
nasopharynx, hypopharynx, and larynx
- Unable or unwilling to complete NDII (baseline only)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Patient with severe, active co-morbidity that would preclude an elective or completion
neck dissection
- Pregnancy and breast-feeding mothers
- Incomplete resection of oral cavity lesion with a positive margin; however, an
excisional biopsy is permitted
- Prior surgery involving the lateral neck, including neck dissection or gross injury to
the neck that would preclude surgical dissection for this trial. Prior thyroid and
central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious
nodes that are ≥ 1 cm with radiographic finding suggestive of NOT malignant should be
biopsied using ultrasound-guided (U/S-guided) fine-needle aspiration (FNA) biopsy
- Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic
leukemia [CLL]) or other active disease capable of causing lymphadenopathy
(sarcoidosis or untreated mycobacterial infection)
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte
or immunomodulatory therapy
- Currently participating in another investigational therapeutic trial
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Team Head and Neck
secure-headandneckresearch@lists.stanford.edu
I'm interested
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.