Therapy of locally unresectable pancreatic carcinoma: A randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil. The gastrointestinal tumor study group

C G Moertel(Mayo Clinic), Stephen Frytak(Mayo Clinic), R. G. Hahn(Mayo Clinic), M. J. OʼConnell(Mayo Clinic), Richard J. Reitemeier(Mayo Clinic), Joan Rubin(Mayo Clinic), Allan J. Schutt(Mayo Clinic), L. H. Weiland(Mayo Clinic), Donald S. Childs(Mayo Clinic), Margaret A. Holbrook(Mayo Clinic), Philip T. Lavin(Frontier Science & Technology Research Foundation), Elliot M. Livstone(Yale University), Harry Spiro(Yale University), Arthur H. Knowlton(Yale University), Martin H. Kalser(University of Miami), Jamie S. Barkin(University of Miami), Howard E. Lessner(University of Miami), Richard Kaplan(University of Miami), Kenneth P. Ramming(California Sea Grant), Harold O. Douglas(Roswell Park Comprehensive Cancer Center), P. Thomas(Roswell Park Comprehensive Cancer Center), Heike Nave(Roswell Park Comprehensive Cancer Center), Joseph R. Bateman(LAC+USC Medical Center), Jacob J. Lokich(Dana-Farber Cancer Institute), J. Renée Brooks(Dana-Farber Cancer Institute), John T. Chaffey(Dana-Farber Cancer Institute), Joseph M. Corson(Dana-Farber Cancer Institute), Norman Zamcheck(Dana-Farber Cancer Institute), Joel W. Novak(Emmes (United States))
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Abstract

One-hundred-ninety-four eligible and evaluable patients with histologically confirmed locally unresectable adenocarcinoma of the pancreas were randomly assigned to therapy with high-dose (6000 rads) radiation therapy alone, to moderate-dose (4000 rads) radiation + 5-fluorouracil (5-FU), and to high-dose radiation plus 5-FU. Median survival with radiation alone was only 51/2 months from date of diagnosis. Both 5-FU-containing treatment regimens produced a highly significant survival improvement when compared with radiation alone. Forty percent of patients treated with the combined regimens were still living at one year compared with 10% of patients treated with radiation only. Survival differences between 4000 rads plus 5-FU and 6000 rads plus 5-FU were not significant with an overall median survival of ten months. Significant prognostic variables, in addition to treatment, were pretreatment performance status and pretreatment CEA level.


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