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Enrollment dogs radiotherapy trial for breast ca. (Only 1% Full).

OB GYN News

| April 01, 2002 | Jancin, Bruce | COPYRIGHT 2002 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

SAN ANTONIO -- In the first year and a half of a major randomized clinical trial of radiotherapy for breast cancer patients with one to three positive lymph nodes, investigators have succeeded in enrolling a mere 24 out of a planned 2,500 participants.

The anemic accrual has breast cancer patient advocates hopping mad. Dr. Allen Lichter, an organizer of the multicenter trial, isn't too happy about the situation either.

"This is a critically important trial. There are a large number of patients out there with one to three positive nodes. We are going to sit and argue about this issue [of whether they benefit from radiotherapy] for eternity unless we put patients in this trial," Dr. Lichter said at the annual breast cancer symposium sponsored by the San Antonio Cancer Institute.

Part of the explanation for the slow accrual lies in the initial study design. Until recently, patients weren't told they were candidates for a randomized trial until after they'd completed systemic chemotherapy. At that ...

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