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Rödel, Claus; Liersch, Torsten; Hermann, Robert Michael; Arnold, Dirk; Reese, Thomas; Hipp, Matthias; Fürst, Alois; Schwella, Nimrod; Bieker, Michael; Hellmich, Gunter; Ewald, Hermann; Haier, Jörg; Lordick, Florian; Flentje, Michael; Sülberg, Heiko; Hohenberger, Werner; Sauer, Rolf

Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer

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  • Media type: E-Article
  • Title: Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer
  • Contributor: Rödel, Claus; Liersch, Torsten; Hermann, Robert Michael; Arnold, Dirk; Reese, Thomas; Hipp, Matthias; Fürst, Alois; Schwella, Nimrod; Bieker, Michael; Hellmich, Gunter; Ewald, Hermann; Haier, Jörg; Lordick, Florian; Flentje, Michael; Sülberg, Heiko; Hohenberger, Werner; Sauer, Rolf
  • imprint: American Society of Clinical Oncology (ASCO), 2007
  • Published in: Journal of Clinical Oncology
  • Language: English
  • DOI: 10.1200/jco.2006.08.3675
  • ISSN: 0732-183X; 1527-7755
  • Keywords: Cancer Research ; Oncology
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Purpose</jats:title><jats:p> To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m<jats:sup>2</jats:sup> on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m<jats:sup>2</jats:sup> on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m<jats:sup>2</jats:sup> bid on days 1 to 14; oxaliplatin 130 mg/m<jats:sup>2</jats:sup> on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment. </jats:p></jats:sec>
  • Access State: Open Access