PURPOSE: To establish the feasibility and efficacy of capecitabine in 
combination with weekly irinotecan (CAPIRI) with concurrent pelvic radiotherapy 
(RT) in patients with locally advanced rectal cancer.
PATIENTS AND METHODS: Nineteen patients with rectal cancer clinical stage T3-4, 
Nx received weekly irinotecan 50 mg/m(2) (days 1, 8, 15, 22, 29) and two doses 
of capecitabine (days 1 through 38; dose level [DL] I, 500 mg/m(2) bid; DL II, 
625 mg/m(2) bid) according to phase I methodology. Three-dimensional conformal 
RT was given to a dose of 50.4 Gy (45 Gy + 5.4 Gy).
RESULTS: On DL I, no dose-limiting toxicities occurred, whereas diarrhea grade 3 
affected three of seven patients on DL II. Twelve patients were treated on DL I 
and received a median relative dose-intensity of 100% for both drugs. Grade 3 or 
4 adverse events were observed in only one of these patients (asthenia grade 3). 
All patients underwent surgery and R0 resection was achieved in all patients. 
Pathologic complete remission was observed in four patients and another five 
patients had only microfoci of residual tumor.
CONCLUSION: Preoperative chemoradiotherapy with CAPIRI is feasible and well 
tolerated. The preliminary efficacy is good, and the tolerability is at least 
comparable with data for fluorouracil plus irinotecan chemoradiotherapy. Larger 
phase II trials of the CAPIRI-RT schedule clearly are warranted.