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My name is Daniel Normolle,
and I am the Director of Biostatistics
at the University of Pittsburgh
I'm going to be discussing
three case studies
of adaptive early phase
clinical trials today.
The first trial involves
the use of gemcitabine,
oxaliplatin, and radiation therapy
in pancreatic cancer.
This is a dose-escalation trial
The second trial is an example
of stereotactic beam radiotherapy
for intrahepatic cancer using an assay
radiation-induced liver disease.
And the third trial will be
a discussion of fish oil
as a colon cancer chemopreventitive.
These are the topics I'm going
to address in the first trial.
Basically, this is a TITE-CRM trial,
and we're going to look at first
the scientific background
of the use of oxaliplatin along
with gemcitabine and radiation therapy.
I'm going to talk about
the operating characteristics
of the TITE-CRM trial.
Why we chose it.
How it gets implemented,
and the results.
So in the vast majority of patients,
pancreatic cancer remains incurable.
It's a fatal disease.
with potentially curative resection
may benefit from chemoradiotherapy.
When this trial was conceived in 2003,
radiation treatment of 54 Gy
over six weeks
with concurrent gemcitabine
was the standard
at the University of Michigan.
approved by the FDA in 2002,
was of great interest.
The recommended phase
2 dose of oxaliplatin,
when administered concurrently
with radiation therapy
and gemcitabine, was to be determined.
We were going to test
six levels of this treatment.
Level -1 was a fallback level
we did not intend to visit.
We were going to escalate oxaliplatin.
And if oxaliplatin was successfully
escalated to 85 mg/m2,
we would then increase
the dose of gemcitabine.
The levels are not scaled
but they are ordered
in terms of intensity.