Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer.

• Abstract: PURPOSE: 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. PATIENTS AND METHODS: 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/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 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/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 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. RESULTS: 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. CONCLUSION: 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.
• Authors: Claus Rödel, Torsten Liersch, Robert Michael Hermann, Dirk Arnold, Thomas Reese, Matthias Hipp, Alois Fürst, Nimrod Schwella, Michael Bieker, Gunter Hellmich, Hermann Ewald, Jörg Haier, Florian Lordick, Michael Flentje, Heiko Sülberg, Werner Hohenberger, Rolf Sauer (Affiliation: Department of Radiotherapy, University of Erlangen-Nürnberg, Erlangen, Germany. claus.roedel at strahlen.med.uni-erlangen.de)
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 25 Issue 1 Pg. 110-7 (Jan 1 2007) ISSN: 1527-7755 [Electronic] United States
• PMID: 17194912 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• capecitabine
• Fluorouracil
• oxaliplatin
• Deoxycytidine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemotherapy, Adjuvant
• Combined Modality Therapy (methods)
• Deoxycytidine (administration & dosage, analogs & derivatives, therapeutic use)
• Female
• Fluorouracil (administration & dosage, analogs & derivatives, therapeutic use)
• Humans
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, therapeutic use)
• Rectal Neoplasms (drug therapy, radiotherapy, surgery)
• Remission Induction
• Treatment Outcome