A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
OBJECTIVES:
Primary
- Determine the negative predictive value of PET/CT imaging based upon pathologic
sampling of the neck lymph nodes in patients with head and neck cancer planning to
undergo N0 neck surgery.
- Determine the potential of PET/CT imaging to change treatment.
Secondary
- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult
metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local
sites.
- Determine the effect of other factors (e.g., tumor size, location, secondary primary
tumors, or intensity of FDG uptake) that can lead to identification of subsets of
patients that could potentially forego neck dissection or that can provide preliminary
data for subsequent studies.
- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer
vs current good clinical practices.
- Evaluate the incidence of occult distant body metastasis discovered by whole-body
PET/CT imaging.
- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
- Evaluate the quality of life of these patients, particularly of those patients whose
management could have been altered by imaging results.
- Evaluate PET/CT imaging and biomarker data for complementary contributions to
metastatic disease prediction.
- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct
assessment of their prediction of recurrence, disease-free survival, and overall
survival.
- Determine the proportion of neck dissections that are extended (i.e., additional levels
that clinicians intend to dissect beyond the initial surgery plan) based on
local-reader PET/CT imaging findings shared with the surgeon before dissection.
- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy
of PET/CT imaging.
- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites
(defined by anatomic location).
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients
undergo unilateral or bilateral neck dissection.
Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months
after surgery.
Patients undergo blood and tissue sample collection periodically for biomarker analysis.
Patients are followed up periodically for up to 2 years after surgery.
Not recruiting | Head and Neck Cancers | Multisite
Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide,
abiraterone and prednisone. Treatment will continue until disease progression or
unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years
post study treatment. The primary and secondary objectives are described below.
1. Primary Objective:
To compare the overall survival of patients with progressive metastatic
castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or
enzalutamide with abiraterone and prednisone
2. Secondary Objectives:
- To assess the grade 3 or higher toxicity profile and compare safety by treatment
arm.
- To assess and compare post-treatment prostate-specific antigen (PSA) declines by
treatment arm.
- To compare radiographic progression free survival defined by Prostate Cancer
Working Group 2 (PCWG2), and objective response rate, by treatment arm.
- To test for radiographic progression free survival (rPFS) treatment interaction in
predicting overall survival.
- To assess pre- and post-treatment measures of tumor burden and bone activity using
sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT)
and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate
these measures with overall survival.
- To develop and validate prognostic and predictive models of overall survival that
include baseline clinical and molecular markers.
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease
PRIMARY OBJECTIVES:
I. To evaluate and compare progression free survival (PFS) of two different doses of
carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or
refractory disease.
SECONDARY OBJECTIVES:
I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates
(RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high
dose carfilzomib.
III. To evaluate the safety of this combination for this patient population. IV. To evaluate
overall survival (OS).
TERTIARY OBJECTIVES:
I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow
relapse sites.
II. To explore the role of positron emission tomography (PET) scanning in assessing disease
burden and as a tool to assess treatment response.
III. To explore changes in left ventricular ejection fraction (LVEF) in patients with
relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose
carfilzomib plus dexamethasone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over
2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II.
ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on
days 1, 2, 8, 9, 15, and 16.
Note that for the first course of treatment on both arms carfilzomib is given at a reduced
rate to assess toxicity.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years
from initial registration.
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