Radiation Oncology/RTOG Trials/9413

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  • Title: A Phase III Trial Comparing Whole Pelvic Irradiation Followed by a Conedown Boost to Boost Irradiation Only and Comparing Neoadjuvant to Adjuvant Total Androgen Suppression (TAS)
  • Objectives:
    • (1) To test the hypothesis that TAS and whole pelvic irradiation followed by a conedown boost to the prostate improves the progression-free survival (an "early endpoint") by at least 10% at 5 years compared to TAS and prostate only irradiation.
    • (2) To test the hypothesis that induction (neoadjuvant) and concurrent TAS and RT, improves the progression-free survival (an "early endpoint") compared to adjuvant TAS and RT by at least 10% at 5 years. (10/13/95)
  • Protocol:
    • Arm 1: Neoadjuvant TAS 2 months before and during RT to the whole pelvis + prostate boost (70.2 Gy)
    • Arm 2: Neoadjuvant TAS 2 months before and during 70.2 Gy RT to prostate only (70.2 Gy)
    • Arm 3: RT to the whole pelvis + prostate boost (70.2 Gy) followed by 4 months of TAS
    • Arm 4: RT to the prostate only (70.2 Gy) followed by 4 months of TAS
  • Eligibility: Risk of LN involvement >15% based on pretreatment PSA and GS, N0M0; must not be eligible for RTOG 94-08
  • Enroll Target: 1200 patients
  • Activation: April 1, 1995
  • Closed: June 1, 1999
  • Conclusion:
    • PMID 12743142 -- Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413 (Roach M, JCO, 2003). Conclusion: WP RT + NCHT improves PFS compared with PO RT and NCHT or PO RT and AHT, and compared with WP RT + AHT in patients with a risk of LN involvement of 15%.
  • Publications:
    • PMID 17011443, 2006 — "Whole-pelvis, "mini-pelvis," or prostate-only external beam radiotherapy after neoadjuvant and concurrent hormonal therapy in patients treated in the Radiation Therapy Oncology Group 9413 trial." Roach M et al. Int J Radiat Oncol Biol Phys. 2006 Nov 1;66(3):647-53.
    • ASCO Abstract -- Field size and progression free survival (PFS) after neoadjuvant hormonal therapy (HT) and radiotherapy (RT) for prostate cancer: Secondary analysis of RTOG 9413 (Roach M, ASCO 2005). Conclusion:There is a clear volume effect favoring large WP fields in patients with intermediate to high-risk disease. Longer follow-up is required to assess the impact of field size on survival.
    • ASTRO Abstract -- Progression Free Survival (PFS) After Whole-Pelvic (WP) vs Mini-Pelvic (MP) or Prostate Only (PO) Radiotherapy (RT): A Subset Analysis of RTOG 9413, A Phase III Prospective Randomized Trial Using Neoadjuvant and Concurrent (N&CHT) (Roach M, ASTRO 2004). Conclusion:WP RT is associated with an improvement in PFS compared to MP and PO RT in patients with a risk of LN involvement >15%. Late grade 3+ GI toxicity was similar with WP RT compared to MP RT, however both were higher than PO RT. This study supports WP RT as the standard of care for intermediate to high risk prostate cancer treated with RT & N&CHT. Longer follow-up is required to determine if this subset analysis eventually translates into a survival difference.
    • ASTRO Abstract -- Dosimetric Consequences to the Pelvic Lymph Nodes Due to the Daily Motion of the Prostate (Chen H, ASTRO 2004). Conclusion: Movement of the entire pelvic field according to the prostate motion has a significant impact on the coverage of the lymph nodes and the planned DVHs of surrounding normal tissues. The degree of impact depends on the magnitude of the movement and the margins used for the relevant structures. For patients with large (> 10mm) prostate movements in the anterior direction, the small bowel doses increased substantially while the coverage of the presacral nodes was compromised. Conversely, large posterior moves put the external iliac nodes at risk for being under-treated. For the IMRT plans, our preliminary results suggest that the prostate motion could cause serious under-dosage of the lymph nodes.
    • PMID 12967640 -- Cytokine profiles in patients receiving wide-field + prostate boost radiotherapy (xRT) for adenocarcinoma of the prostate (Kovacs CJ, Cytokine, 2003). Conclusion: Patients with prostate cancer (PC) were found to have a significantly (p<0.05) elevated plasma level of the three cytokines prior to treatment. Moreover, during WFP + PB xRT, these circulating cytokine levels were further elevated, the elevation occurring in the form of cyclic waves; the concurrent waves of elevated IL-1alpha and M-CSF preceding that of TGFbeta. In addition to providing support for the existence of a humoral response to xRT in patients receiving WFP + PB xRT, the data demonstrated a significant correlation between the integral radiation dose (ID) and the temporal expression and magnitude of plasma IL-1alpha, M-CSF and TGFbeta levels in patients that had received 1-5 fractions (1.8-9Gy) of WFP + PB xRT. Thereafter, the appearance of elevated waves of cytokine expression in the patient's plasma continued independent of additional fractions of WFP + PB xRT.
    • PMID 12728440 -- The evolving role of pelvic radiation therapy. (Roberts T, Semin Radiat Oncol, 2003). Review.
    • ASCO Abstract -- Neoadjuvant hormonal therapy (NHT) with whole-pelvic (WP) radiotherapy (RT) improves progression-free survival (PFS): RTOG (Radiation Therapy Oncology Group) 9413, a phase III randomized trial. (Roach M, ASCO 2002). Conclusion: Prophylactic WP RT and NHT reduced the risk of disease progression for patients with high-risk prostate cancer. However, NHT combined with RT was no more effective than AHT when only the prostate was irradiated and WP RT was no more effective than PO RT without NHT.