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The standard treatment for locally advanced rectal cancer (LARC) patients is based on neoadjuvant chemo-radiation or short-course radiotherapy followed by TME surgery. In the recent years, several studies assessed induction and consolidation strategies, anticipating chemotherapy before surgery, in order to achieve a better control on micrometastatic disease and to increase complete pathologic response (pCR) rate.
FOLFOXIRI is a regimen routinely employed in metastatic colorectal cancer patients which demonstrated higher response rate, progression free survival and overall survival.
On the basis of these considerations, we designed the present phase II trial of short-
course radiotherapy followed by consolidation chemotherapy with FOLFOXIRI and surgery in order to assess the role of the triplet as consolidation strategy in patients with middle-high LARC.

Selection criteria

  • Patients aged ≥18 and < 70 years with ECOG ≤1;
  • patients with pathologically confirmed locally advanced rectal cancer defined by the presence of at least one of the following features:
    • cN2 (defined as at least 4 positive lymphnodes at pelvic MRI),
    • cT4,
    • tumor extending to within 1 mm of or beyond mesorectal fascia (i.e., circumferential radial margin threatened or involved),
    • cT3, N1;
  • distal border of the tumour located between 5 and 12 cm from the anal verge (as measured by pelvic MRI);
  • adequate hematopoietic, liver and renal function.


The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR).

Participating centers