This trial closed to accrual on 6/01/99. Two hundred and forty-one patients had been accessioned nationally. Three patients were accessioned by Johns Hopkins. One patient was randomized to Arm I on 6/1/98 - (70 Gy/7 weeks plus daily cisplatin and 5-Fu during last 10 days of XRT). Two patients were randomized to Arm II (1st on 12/30/98 2nd on 4/13/99) --(70 Gy/13 weeks plus daily hydroxyurea and 5-Fu.One patient has since expired on 02/10/03. The two remaining patients are still being followed annually for survival and disease status.
The preliminary results from this trial suggest a substantial reduction in death rates in patients treated on all 3 arms compared with radiation alone or radiation and cisplatin.
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