Phase II trial of preoperative 3D conformal radiotherapy, protracted venous infusion 5-fluorouracil, and weekly CPT-11, followed by surgery for ultrasound-staged T3 rectal cancer.

摘要: Abstract Purpose: CPT-11 sensitizes tumor cells to radiation and in combination therapy with 5-fluorouracil (5-FU) results enhanced cytotoxicity metastatic colorectal cancer. We report the from a Phase II trial of preoperative radiotherapy (RT), CPT-11, 5-FU for patients ultrasound-staged T3 rectal Methods Materials: Between April 1999 August 2001, 32 (21 men, 11 women; median age 52 years, range 40–74) biopsy-proven adenocarcinoma rectum were enrolled study. All underwent endorectal ultrasonography staging (uT3N0 = 19; uT3N1=13; uT2N1=1). RT was prescribed draining lymph nodes (45 Gy 1.8-Gy daily fractions) (50.4 fractions). Patients also received concurrent (50 mg/m 2 , Days 1, 8, 15, 22) (200 daily, 7 d/wk, 1–33). Surgical resection performed 6–10 weeks after completing chemoradiotherapy. Results: Acute toxicity frequently observed, 18 (56%) required either chemotherapy dose reduction or interruption >3 days. One patient withdrew because diarrhea abdominal cramping (Grade III) 10 days treatment. Although no Grade IV III ( n 9, 28%), mucositis 7, 21%), sores 3, 9%) noted. Of who surgery, 12 had complete pathologic response. patients, disease 23 (71%) downstaged. The average length hospitalization between 5 days, 1 staying 33 followed disease-free survival. Conclusion: associated frequent acute toxicity, regimen is significant "downstaging." Additional longer follow-up are necessary define role this fully.