The study was closed to accrual on 5/31/00 having met its accrual goals. Five Hundred forty-seven patients were accessioned nationally. Ten patients were accessioned by Johns Hopkins. Three patients were randomized to ARM I (CDDP/5-FU+RT), 4 to ARM II(RT+CDDP), and 3 to ARM III(RT alone). Two patients are alive and continue in follow-up.
-One patient recurred and expired.
-One patient is alive and continues in follow-up.
-Two patients expired from non-cancer related causes. One patient developed a second malignancy and expired.
-One patient developed liver mets and expired.
-One patient has expired from a non-cancer related cause.
-After failing RT patient had total laryngectomy, is now disease free and continues in follow up.
In conclusion, concomitant chemotherapy and radiotherapy was superior for laryngeal preservation rate and loco-regional control compared with induction chemotherapy followed by radiotherapy and compared to radiotherapy alone. Patients on concomitant treatment had a superior LFS compared to patients treated with radiation alone. There was no significant difference between induction chemotherapy and radiotherapy alone using these criteria. Better local control with the concomitant treatment arm did not improve survival.
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