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Delayed Lung Cancer Screening Trial to Begin Enrollment 50,000 Subjects

Delayed Lung Cancer Screening Trial to Begin Enrollment 50,000 Subjects

BETHESDA, Maryland—A lung cancer screening trial supported by the National
Cancer Institute (NCI) that will compare spiral CT and standard chest
x-ray is back on track after being delayed for several months. Andrew von
Eschenbach, MD, ordered a review of the planned 50,000-subject study, expected
to cost about $200 million, soon after becoming NCI director in January.

"It is obviously a very significant commitment with regard to the
financial investment," Dr. von Eschenbach told the National Cancer
Advisory Board. "Before launching the study, I wanted to be absolutely
certain that we had exercised due diligence to ensure that all issues were
thoroughly addressed."

A major result of the review will be an expansion of the number of research
centers participating in the National Lung Screening Trial (NLST) to 30 from
the originally intended 20 sites. Enrollment should begin later this year.

As part of the review, NCI discussed the trial plan and protocol with
researchers who will conduct it and with people in the cancer community who had
expressed concerns about many of the details of the 8-year study. "It was
an opportunity to do some additional fine tuning of the study that I think will
enhance its impact and increase our confidence level that it will yield
appropriate, meaningful results, and do it in a timely fashion," Dr. von
Eschenbach said.

The additional 10 research sites "will help us to front-load the study
as far as accrual in a much more effective way," he added. "The
quicker we can accrue to this trial, the more people we can enter at the very
beginning, the more likely it is that we will get more meaningful results in an
early period of time. And that, in turn, will translate into very significant
cost savings."

NCI has also removed accrual allocations from the study in an effort to
speed up recruitment. Each center can enroll as many participants as possible
until the accrual goal is met. In addition, the American Cancer Society has
pledged $1 million a year for the first 5 years of the NLST to help NCI cover
the study’s costs. The Institute is also in discussions with the American
Legacy Foundation "that may result in some additional financial
contributions to the study," Dr. von Eschenbach said.

Both spiral CT, also known as helical CT, and chest x-rays can detect lung
cancer. Several studies in the United States and Japan have shown that spiral
CT can detect tumors well below 1 cm. The smallest tumors picked up by standard
chest x-rays range from 1 to 2 cm. However, there is no conclusive evidence
that screening or early detection reduces a patient’s risk of dying of lung
cancer.

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