Radiation Oncology/RTOG Trials/9019

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  • Link to textbook
  • This is a SWOG-8794 Study (INT-0086, CALGB-9493, EST-9887)
  • Title: A Phase III Study of the Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy
  • Objectives:
    • (1) To compare the disease-free survival rates in completely resected patients with pathologic stage C (T3N0M0) carcinoma of the prostate assigned to be treated with adjuvant external beam radiotherapy to that in patients assigned to receive no adjuvant therapy
    • (2) To assess the qualitative and quantitative toxicities of patients with pathologic stage C (T3N0M0) carcinoma of the prostate when treated with external beam radiotherapy.
  • Protocol:
    • Arm 1: Radical Prostatectomy
    • Arm 2: Radical Prostatectomy + 60-64 Gy EBRT
  • Eligibility: Status Post RP, +ECE or +SVI or +SM, N0M0
  • Activation: August 15, 1988 (RTOG Activation: April 20, 1992)
  • Closed: January 1, 1997
  • Publications:
    • 2007 PMID 17538167 -- "Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794." (Swanson GP, J Clin Oncol. 2007 Jun 1;25(16):2225-9.) Conclusion: Failure in high risk patients predominately local; adjuvant RT reduces risk of failure
    • 2006 PMID 17105795 — "Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial." (Thompson IM Jr et al. JAMA. 2006 Nov 15;296(19):2329-35.) Conclusion: Adjuvant radiotherapy resulted in significantly reduced risk of PSA relapse and disease recurrence, although the improvements in metastasis-free survival and overall survival were not statistically significant.
    • 2005 ASTRO Abstract Plenary #1, 2005 Webcast - "Phase III Randomized Study of Adjuvant Radiation Therapy versus Observation in Patients with Pathologic T3 Prostate Cancer (SWOG 8794)" Swanson GP et al. IJROBP Volume 63, Supplement 1 , 1 October 2005, Page S1.
    • 1994 No Abstract -- "An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing." (Thompson IM, Urology 1994). Review
    • 1992 -- "Adjuvant Radiotherapy Following Radical Prostatectomy for Pathologic Stage C Adenocarcinoma of the Prostate: Initial Evaluation of Toxicity." I Thompson, ED Crawford, G Miller, J Paradelo, B Blumenstein, M Wolf, C Moinpour, K Hayden. American Society of Clinical Oncology 11:212 (#663), 1992.