Radiation Oncology/RTOG Trials/8319

RTOG 83-19 (LIVER) Title: Phase III Randomized Comparison of ADR/5-FU plus I131-Antiferritin IgG vs ADR/5-FU Alone Following ADR/5-FU plus External Beam Radiotherapy in Nonmetastatic Nonresectable Primary Hepatoma Objective: I. Determine the therapeutic efficacy of cyclic I131-antiferritin IgG plus adriamycin/5-fluorouracil vs. adriamycin/5-fluorouracil alone following induction with external beam irradiation plus adriamycin/5-fluorouracil in patients with nonmetastatic, nonresectable primary hepatoma. II. Determine both survival and the incidence of tumor volumetric reduction of at least 30 percent in the two treatment arms. III. Study the relationship between duration of remission and AFP negativity. Protocol: Induction RT (21.0 Gy at 3.0 Gy/Fx) + low-dose CT (5-FU/adriamycin) followed 1 month later by: Arm 1: adriamycin/5-FU + 131-I-antiferritin Arm 2: adriamycin/5-FU Eligibility: Histologically proven primary hepatoma that is nonresectable and from which there are no known extrahepatic metastases. Patients with positive AFP titers are excluded. Enrolled: Conclusion: 1850722 -- A randomized prospective trial comparing full dose chemotherapy to 131I antiferritin: an RTOG study. (1991 Order S, Int J Radiat Oncol Biol Phys. 1991 May;20(5):953-63.) Conclusion: "Overall, radiolabeled antibody administration and full dose chemotherapy led to equivalent partial remission rates (22-30% vs 23-25%) and survival rates compared to chemotherapy (6 month median; AFP+ 5 months; AFP- 10 months)." Publications: 9612600 -- Survival results among patients with alpha-fetoprotein-positive, unresectable hepatocellular carcinoma: analysis of three sequential treatments of the RTOG and Johns Hopkins Oncology Center. (Abrams RA, Cancer J Sci Am. 1998 May-Jun;4(3):178-84.) Conclusion: "Intravenous 131I-polyclonal antiferritin did not improve survival when added to either post-induction regimen but dramatically increased hematologic toxicities."