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.
A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma
This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Glofitamab
- drug: Tocilizumab
- drug: Doxorubicin
- drug: Vincristine
- drug: Prednisone
- drug: Rituximab
- drug: Cyclophosphamide
Eligibility
Inclusion Criteria:
- Previously untreated patients with CD20-positive DLBCL, including one of the following
diagnoses made according to the 2016 World Health Organization (WHO) classification of
lymphoid neoplasms
- DLBCL, not otherwise specified, including GCB and ABC/non-GCB types as well as
double-expressor lymphoma (coexpression of MYC and BCL2)
- High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 translocations
- Patients with de novo transformed follicular lymphoma (patients with discordant
bone marrow involvement, i.e., evidence of low-grade histology in bone marrow)
may be considered after discussion with the Medical Monitor
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- International Prognostic Index (IPI): 2-5
- Life expectancy of at least 6 months
- Adequate biomarker blood samples prior to initiation of R-CHOP on Day 1 of Cycle 1 and
on Day 1 of Cycle 2 submitted for screening for determination of ctDNA status
- At least one bi-dimensionally fluorodeoxyglucose (FDG)-avid measurable lymphoma lesion
on positron emission tomography/computed tomography (PET/CT) scan
- Left ventricular ejection fraction (LVEF) >=50%, as determined on cardiac
multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematopoietic function
- Contraception use
Additional Inclusion Criterion for ctDNA High-Risk Participants:
- Plasma sample evaluated to be ctDNA high risk
Exclusion Criteria:
- Current diagnosis of B-cell lymphoma, unclassifiable, with features intermediate
between DLBCL and classic Hodgkin lymphoma (gray-zone lymphoma), primary mediastinal
(thymic) large B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, Burkitt
lymphoma, central nervous system (CNS) lymphoma (primary or secondary involvement),
primary effusion DLBCL, and primary cutaneous DLBCL
- Contraindication to any of the individual components of R-CHOP, including prior
receipt of anthracyclines, history of severe allergic or anaphylactic reactions to
murine monoclonal antibodies, or known sensitivity or allergy to murine products
- Prior treatment for indolent lymphoma
- Prior solid organ or allogeneic stem cell transplant
- Prior therapy for DLBCL and high-grade B-cell lymphoma (HGBCL) with the exception of
palliative, short-term treatment with corticosteroids
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
12 months after the final dose of R-CHOP, 3 months after the final dose of tocilizumab
(if applicable), or 2 months after the final dose of glofitamab
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
Austin Yeung
ahyeung@stanford.edu
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.