Radiation Oncology/RTOG Trials/8301

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RTOG 83-01 (LIVER)

  • Title: Phase I/II evaluation of I-131 Antiferritin after RT/CT induction
  • Objective:
    • I. Provide the necessary data to determine the maximum safe dose of adriamycin and 5-fluorouracil that can be combined with I-131 antiferritin IgG (given 30 mCi on day 0 and 20 mCi on day 5).
    • II. Determine whether 20 mCi I-131 anti-AFP plus 30 mCi antiferritin increases tumor dose deposition and offers advantage in tumor effective half-life and dose deposition over I-131 antiferritin alone.
    • III. Combine the radiolabeled preparation considered best (on dosimetric grounds) with escalating doses of adriamycin and 5-fluorouracil.
    • IV. Determine the best combination of adriamycin and 5-fluorouracil plus I-131 labeled antibody for Phase II trial in AFP and non-AFP hepatomas.
    • V. Complete Phase II trials using physical exam and CT tumor volume reconstruction to determine the remission rate, duration of remission, and survival.
  • Protocol:
    • Induction RT (21.0 Gy at 3.0 Gy/Fx or 24.0 Gy at 1.5 Gy/Fx BID) + low-dose CT (5-FU/adriamycin)
    • 1 month later I-131-antiferritin + 5-FU/adriamycin
  • Eligibility: histologically confirmed primary hepatic malignancy
  • Enrolled: 216 patients
  • Conclusion:
    • PMID 2415692 -- Iodine 131 antiferritin, a new treatment modality in hepatoma: a Radiation Therapy Oncology Group study. (Order SE, J Clin Oncol. 1985 Dec;3(12):1573-82.) Conclusion: "These studies have demonstrated the toxicity and therapeutic activity of 131I antiferritin and the emerging role of radiolabelled antibody in cancer therapy."
  • Publications:
    • 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)."
    • PMID 1847127 -- Prognostic factors in unresectable hepatocellular cancer: Radiation Therapy Oncology Group Study 83-01. (Stillwagon GB, Int J Radiat Oncol Biol Phys. 1991 Jan;20(1):65-71.) Conclusion: "Good and poor prognostic groups were defined and compared to a similar patient population (RTOG study 83-19) with confirmation of the validity of the model"
    • PMID 2998178 -- Computed tomography assisted volumetric analysis of primary liver tumor as a measure of response to therapy. (Ettinger DS, Am J Clin Oncol. 1985 Oct;8(5):413-8.) Conclusion: "In spite of small changes in total liver volume, there may be concomitantly substantial changes in tumor volume.
    • PMID 6085756 -- Comparative tumor dose from 131I-labeled polyclonal anti-ferritin, anti-AFP, and anti-CEA in primary liver cancers. (Leichner PK, Cancer Drug Deliv. 1984 Fall;1(4):321-8.) Conclusion: "Polyclonal anti-ferritin has, therefore, become the antibody of choice in the treatment of hepatoma."