The RACOX phase I study: Radiation (RA), capecitabine (C) and oxaliplatin (OX) as adjuvant treatment of stage II and III rectal cancer

Journal of B.U.ON.

Volumn 9, Issue 4, 2004, Pages 383-390

  Bountouroglou, N ^a   Ziras, Nicholas ^a   Sarris, G ^a   Petrides, A ^a   Potamianou, A ^a   Synodinou, M ^a   Karvounis, N ^a   Angelides, A ^a   Chrysanthou, K ^a   Athanassiou, A E ^a  

^a METAXA CANCER HOSPITAL   (Greece)

Author keywords

Adjuvant setting; Capecitabine; Chemotherapy; Oxaliplatin; Radiotherapy; Rectal cancer

Indexed keywords

CAPECITABINE; LOPERAMIDE; OXALIPLATIN;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BEAM THERAPY; BLEEDING; BONE MARROW TOXICITY; CANCER ADJUVANT THERAPY; CANCER PATIENT; CANCER STAGING; CARDIOVASCULAR DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; COLITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTITIS; DERMATITIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG HYPERSENSITIVITY; DRUG TOLERABILITY; DYSESTHESIA; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; FEVER; FLU LIKE SYNDROME; FOLLOW UP; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HEMATURIA; HUMAN; HYPERBILIRUBINEMIA; INFECTION; INSOMNIA; LEUKOPENIA; LIVER DYSFUNCTION; MALE; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUROTOXICITY; NEUTROPENIA; PAIN; PARESTHESIA; PATIENT MONITORING; PHASE 1 CLINICAL TRIAL; PROCTITIS; PROTEINURIA; PRURITUS; RADIATION DOSE; RECTUM CANCER; RECTUM CARCINOMA; RECTUM RESECTION; SENSORY NEUROPATHY; SKIN ALLERGY; SKIN MANIFESTATION; STOMATITIS; TACHYCARDIA; THROMBOCYTOPENIA; TREATMENT PLANNING;

EID: 20044388783     PISSN: 11070625     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (30)

1. Gastrointestinal Tumor Study Group. Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med 1985; 312: 1465-1472.
2. Krook JE, Moertel CG, Gunderson LL et al. Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med 1991; 324: 709-715.
3. NIH Consensus Conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA 1990; 264: 1444-1450.
4. Gastrointestinal Tumor Study Group. Radiation therapy and fluorouracil with or without semustine for the treatment of patients with surgical adjuvant adenocarcinoma of the rectum. J Clin Oncol 1992;10: 549-557.
5. Kachnic LA, Willett CG. Radiation therapy in the management of rectal cancer. Cur Opin Oncol 2001;13: 300-306.
6. Swedish Rectal Cancer Trial. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med 1997; 336: 980-987.
7. O'Connell M, Wieand H, Krook J et al. Lack of value for methyl-CCNU (MeCCNU) as a component of effective rectal cancer surgical adjuvant therapy: interim analysis of intergroup protocol 86-47-51. Proc Am Soc Clin Oncol 1991; 10: A-403, 134 (abstr).
8. Moertel CG. Chemotherapy for colorectal cancer. N Engl J Med 1994; 330: 1136-1472.
9. Kollmorgen CF, Meagher AP, Wolff BG et al. The long-term effect of adjuvant postoperative chemoradiotherapy for rectal carcinoma on bowel function. Ann Surg 1994; 220: 676-682.
10. Petrelli N, Douglas H, Herrera L et al. Modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: A prospective randomized phase III trial. J Clin Oncol 1989; 7: 1419-1426.
11. O'Connell M. A Phase III trial of 5-fluorouracil and leucovorin in the treatment of advanced colorectal cancer: A Mayo Clinic/North Central Cancer Group study. Cancer 1989; 63: 1026-1030.
12. Advanced Colorectal Cancer Meta-Analysis Project. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 1992; 10: 896-903.
13. Poon M, O'Connell M, Wieand H et al. Biochemical modulation of fluorouracil with leucovorin: Confirmatory evidence of improved therapeutic efficacy in advanced colorectal cancer. J Clin Oncol 1991; 9: 1967-1972.
14. Gastrointestinal Tumor Study Group. Radiation therapy and fluorouracil with or without semustine for the treatment of patients with surgical adjuvant adenocarcinoma of the rectum. J Clin Oncol 1992; 10:549-557.
15. Tepper JE, O'Connell M, Niedzwiecki D et al. Adjuvant therapy in rectal cancer: Analysis of stage, sex, and local control: Final report of Intergroup 0114 trial. J Clin Oncol 2002; 20:1744-1750.
16. O'Connell MJ, Martenson JA, Wieand HS et al. Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 1994; 331:502-507.
17. Schuller J, Cassidy J, Dumont E et al. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000; 45:291-297.
18. Sawada N, Ishikawa T, Sekiguchi F et al. X-ray irradiation induces thymidine phosphorylase and enhances the efficacy of capecitabine (Xeloda) in human cancer xenografts. Clin Cancer Res 1999; 5:2948-2953.
19. Dunst J, Reese T, Sutter T et al. Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol 2002; 20:3983-3991.
20. Zalcberg J, Ngan S, Michael M et al. Observed toxicities in a phase I study of preoperative radiotherapy combined with capecitabine for locally advanced, potentially resectable rectal cancer. Ann Oncol 2002; 13:81 (abstr).
21. de Gramont A, Figer A, Seymour M. et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18:2938-2947.
22. Giacchetti S, Perpoint B, Zidani R et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000; 18:136-147.
23. Giacchetti S, Itzhaki M, Gruia G et al. Long-term survival of patients with unresectable colorectal liver metastases following infusional chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and surgery. Ann Oncol 1999; 10:663-669.
24. Cividalli A, Ceciarelli F, Livdi E et al. Radiosensitization by oxaliplatin in a mouse adenocarcinoma: Influence of treatment schedule. Int J Radiat Oncol Biol Phys 2002; 52:1092-1098.
25. Diaz-Rubio E, Evans TR, Tabernero J et al. Capecitabine (Xeloda) in combination with oxaliplatin: A phase I, dose-escalation study in patients with advanced or metastatic solid tumors. Ann Oncol 2002; 13:558-565.
26. Borner MM, Dietrich D, Stupp R et al. Phase II study of capecitabine and oxaliplatin in first- and second-line treatment of advanced or metastatic colorectal cancer. J Clin Oncol 2002; 20:1759-1766.
27. Trotti A, Byhardt R, Stetz J et al. Common toxicity criteria: Version 2.0: An improved reference for grading the acute effects of cancer treatment: Impact on radiotherapy. Int J Radiat Oncol Biol Phys 2000; 47:13-47.
28. Piantadosi S (ed). Clinical Trials: A methodologic perspective. New York, NY, John Wiley, 1997, pp 151-155.
29. Freyer G, Bossard N, Romestaing P et al. Addition of oxaliplatin to continuous fluorouracil, l-folinic acid, and concomitant radiotherapy in rectal cancer: The Lyon R 97-03 phase I trial. J Clin Oncol 2001; 19:2433-2438.
30. Rodel C, Grabenbauer G, Papadopoulos T, Hohenberger W, Schmoll HJ, Sauer R. Phase I/II Trial of capecitabine, oxaliplatin, and radiation for rectal cancer. J Clin Oncol 2003; 21: 3098-3104.