Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer

Benjamin Movsas, Hasmik Diratzouian, Alexandra Hanlon, Harry Cooper, Gary Freedman, Andre Konski, Elin Sigurdson, John Hoffman, Neal J. Meropol, Louis M. Weiner, Lawrence Coia, Rachelle Lanciano, Joanne Stein, Debra Kister, Burton Eisenberg

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21 Scopus citations

Abstract

PURPOSE: The purpose of this phase II study was to prospectively determine the efficacy of preoperative chemoradiation with a hyperfractionated (Hfx) RT boost to 61.8 Gy in locally advanced rectal cancer. METHODS: Eligibility stipulated that the primary lesion had to be either T4; or T3 and >4 cm or 40% of the bowel circumference. Radiation (RT) consisted of 45 Gy to the pelvis (1.8 Gy per fraction) followed by 1.2 Gy twice daily (to the gross tumor volume) to a total RT dose of 61.8 Gy. There was 5-FU infused at 1 g/m/24 hours for 4 days during the 1st and 6th weeks of RT (concurrent with the Hfx boost). Surgical resection was planned 4 to 6 weeks later. Adjuvant chemotherapy (bolus 5-FU/leucovorin) was scheduled for 4 cycles at 28-day intervals. RESULTS: There were 22 patients, ages 22 to 81 years (median, 64) enrolled in the study. Of the 20 patients evaluable for response, 10 (50%) had evidence of clinical downstaging and 5 patients (25%) had ≥90% fibrosis in the resected specimen. With a median f/u of 40 months (7-158), the 4 years actuarial rate for all patients (n = 22) of OS was 64%, of DFS 62%, and of LC 84%. 3/21 patients (14%) had positive margins, all of whom developed a local failure (P < 0.001). CONCLUSION: This regimen of high dose preoperative chemoRT with a Hfx RT boost (to 61.8 Gy) in patients with bulky, locally advanced rectal cancer results in clinical downstaging in half of the patients with significant fibrosis in the operative specimen.

Original languageEnglish
Pages (from-to)435-441
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume29
Issue number5
DOIs
StatePublished - Oct 2006

Keywords

  • Adenocarcinoma/drug therapy
  • Adult
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic/therapeutic use
  • Combined Modality Therapy
  • Dose Fractionation, Radiation
  • Fluorouracil/therapeutic use
  • Humans
  • Middle Aged
  • Prospective Studies
  • Radiotherapy, High-Energy
  • Rectal Neoplasms/drug therapy
  • Survival Analysis

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