Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer

Abstract

BACKGROUND: Although many trials have shown the efficacy of preoperative chemoradiotherapy (CRT) or postoperative CRT compared with surgery alone, the optimal sequence of radiotherapy and surgery is unclear. The authors reported the final results of this single institution prospective randomized phase 3 trial comparing preoperative CRT with postoperative CRT using capecitabine in survival, local control, sphincter preservation, and toxicity for the treatment of locally advanced rectal cancer. METHODS: Patients with locally advanced rectal cancer (cT3, potentially resectable cT4 or Nþ) were randomly assigned to receive preoperative or postoperative CRT. CRT consisted of 50 Gy/ 25 fractions and concurrent capecitabine (1,650 mg/m

Is There a Role for Adjuvant Chemotherapy in Rectal Cancer?

“…Surviving patients were observed for a median of 8.4 years. A Korean single-institution randomized phase III trial of 240 patients with clinical T3, resectable T4, or node-positive rectal cancer (patients were staged with CT scans and endorectal ultrasound) compared preoperative to postoperative chemoradiotherapy [13]. Chemoradiotherapy consisted of 50 Gy/25 fractions and concurrent capecitabine (1650 mg/m 2 day).…”

Multi-modality Therapy for Rectal Cancer—Past, Present, and Future

“…The use of pre-operative CRT is supported by several randomized trials conducted worldwide. [21][22][23][24] The National Surgical Adjuvant Breast and Bowel Project R-03 (NASBP-R-03) was developed to investigate best timing for the administration of multimodality therapy. 21 In this study, 267 patients were randomly assigned to either received pre-operative CRT (n=130) or postoperative CRT (n=137).…”

“…22 A Korean Trial additionally suggested a benefit for a preoperative CRT approach. 23 This single institution study randomized 240 patients to either pre-operative or postoperative capecitabine with RT followed by four cycles of capecitabine or 5-FU. Although publication of the German Study 22 led to the low accrual/early closure in the Korean trial, patients with low-lying tumors treated with pre-operative CRT similarly demonstrated a higher rate of sphincter-sparing surgeries.…”

“…Although publication of the German Study 22 led to the low accrual/early closure in the Korean trial, patients with low-lying tumors treated with pre-operative CRT similarly demonstrated a higher rate of sphincter-sparing surgeries. 23 The delivery of 5-FU varied considerably between the various trials described above. Currently, however, continuous infusion 5-FU has been adapted by most institutions based on the NCCTG 26 and INT-0114 27 trials suggesting that infusional 5-FU has improved efficacy and decreased hematologic toxicities compared to bolus 5-FU regimens.…”

Strahlentherapie des Rektumkarzinoms

“…Eine koreanische Studie zeigte eine erhöhte Rate an Sphinktererhalt für tiefsitzende Rektumkarzinome durch RCT mit Capecitabine vor TME [12]. Die bisherigen Studienergebnisse und Erkenntnisse bzgl.…”