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:
- PMID 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:
- PMID 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."