Phase I Study of Preoperative Radiation Therapy With Concurrent Infusional 5-Fluorouracil and Oxaliplatin Followed by Surgery and Postoperative 5-Fluorouracil Plus Leucovorin for T3/T4 Rectal Adenocarcinoma: ECOG E1297

International Journal of Radiation Oncology Biology Physics

Volumn 72, Issue 1, 2008, Pages 108-113

  Rosenthal, David I ^a   Catalano, Paul J ^b   Haller, Daniel G ^c   Landry, Jerome C ^d   Sigurdson, Elin R ^e   Spitz, Francis R ^c   Benson III, Al B ^f  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d EMORY UNIVERSITY   (United States)

^e FOX CHASE CANCER CENTER   (United States)

^f NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Chemoradiation; Dose escalation study; Eastern Cooperative Oncology Group; Oxaliplatin; Phase I; Radiation therapy; Rectal cancer

Indexed keywords

PLATINUM; SURGERY;

5-FLUOROURACIL; CHEMORADIATION; COLORECTAL CANCER; DOSE RADIATION; DOSE-ESCALATION STUDY; EASTERN COOPERATIVE ONCOLOGY GROUP; OXALIPLATIN; PHASE I; PREOPERATIVE CHEMORADIATION; RADIATION THERAPY; RADIOSENSITIZER; RECTAL ADENOCARCINOMA; RECTAL CANCER; RECTAL CANCERS;

STANDARDS;

FLUOROURACIL; FOLINIC ACID; OXALIPLATIN;

ABDOMEN; ADULT; AGED; ANEMIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; DECREASED APPETITE; DIARRHEA; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSURIA; FEMALE; FEVER; FLATULENCE; HEMATURIA; HUMAN; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PATHOLOGY; PELVIS; PELVIS PAIN SYNDROME; PHASE 1 CLINICAL TRIAL; POSTOPERATIVE CARE; PREOPERATIVE RADIOTHERAPY; PRIORITY JOURNAL; RADIATION DOSE; RECTAL PAIN; RECTUM CARCINOMA; RECTUM HEMORRHAGE; SIDE EFFECT; SPHINCTER; THROMBOCYTOPENIA; TREATMENT OUTCOME; TUMOR; URINARY FREQUENCY; URINARY TRACT INFECTION; URINE RETENTION; VOMITING; WEIGHT REDUCTION;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COMBINED MODALITY THERAPY; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM STAGING; NEOPLASM, RESIDUAL; ORGANOPLATINUM COMPOUNDS; RADIATION-SENSITIZING AGENTS; RECTAL NEOPLASMS;

EID: 49549098631     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2008.05.054     Document Type: Article

References (26)

1. Gunderson L.L., Sargent D.J., Tepper J.E., et al. Impact of T and N stage and treatment on survival and relapse in adjuvant rectal cancer: A pooled analysis. J Clin Oncol 22 (2004) 1785-1796
2. NIH Consensus Conference [No authors listed]. Adjuvant therapy for patients with colon and rectal cancer. JAMA 264 (1990) 1444-1450
3. Kapiteijn E., Putter H., and van de Velde C.J.H. Impact of the introduction and training of total mesorectal excision on recurrence and survival in rectal cancer in the Netherlands. Br J Oral Maxillofacial Surg 89 (2002) 1142-1149
4. Wibe A., Moller B., Norstein J., et al. A national strategic change in treatment policy for rectal cancer-implementation of total mesorectal excision as routine treatment in Norway. A national audit. Dis Colon Rectum 45 (2002) 857-866
5. Kapiteijn E., Marijnen C.A.M., Nagtegaal I.D., et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345 (2001) 638-646
6. Sauer R., Becker H., Hohenberger W., et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351 (2004) 1731-1740
7. Hess S., and Blackstock A.W. Oxaliplatin: In vitro and in vivo evidence of its radiation sensitizing activity: Preclinical observation relevant to ongoing clinical trials. [Abstract]. Proc Am Assoc Cancer Res (2000) Abstract issue:41
8. Raymond E., Faivre Sc S., Woynarowski J., et al. Cellular and molecular pharmacology of oxaliplatin. Mol Cancer Ther Links 3 (2002) 227-235
9. Diaz-Rubio E., Sastre J., Zaniboni A., et al. Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: A phase II multicentric study. Ann Oncol 9 (1998) 105-108
10. Levi F., Perpoint B., Garufi C., et al. Oxaliplatin activity against metastatic colorectal cancer. A phase II study of 5-day continuous venous infusion at circadian rhythm modulated rate. Eur J Cancer 29A (1993) 1280-1284
11. Machover D., Diaz-Rubio E., de Gramont A., et al. Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines. Ann Oncol 7 (1996) 95-98
12. Becouran Y., Gameliln E., Coudert B., et al. Randomized multicenter phase II study comparing a combination of fluorouracil and folinic acid and alternating irinotecan and oxaliplatin with oxaliplatin and irinotecan in fluorouracil-pretreated metastatic colorectal cancer patients. J Clin Oncol 15 (2001) 4195-4201
13. Tourfigand C., Andre T., Achille E., et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 22 (2004) 229-237
14. Ryan D.P., Niedzwiecki D., Hollis D., et al. Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901. J Clin Oncol 24 (2006) 2557-2562
15. Francois E., Ychou M., Ducreux M., et al. Combined radiotherapy, 5-fluorouracil continuous infusion and weekly oxaliplatin in advanced rectal cancer: A phase I study. Eur J Cancer 41 (2005) 2861-2867
16. Aschele C., Friso M., Puccarelli S., et al. A phase I-II study of weekly oxaliplatin, 5-fluorouracil continuous infusion and preoperative radiotherapy in locally advanced rectal cancer. Ann Oncol 16 (2005) 1140-1146
17. Loi S., Ngan S.Y.K., Hicks R.J., et al. Oxaliplatin combined with infusional 5-fluorouracil and concomitant radiotherapy in inoperable and metastatic rectal cancer: A phase I trial. Br J Oral Maxillofacial Surg 92 (2005) 655-661
18. Ryan D. Novel therapies in colon cancer. Curr Colorectal Cancer Rep 2 (2006) 116-119
19. Rodel C., Martus P., Papadoupolos T., et al. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol 23 (2005) 8688-8696
20. Bouzourene H., Bosman F.T., Seelentag W., et al. Importance of tumor regression assessment in predicting the outcome in patients with locally advanced rectal carcinoma who are treated with preoperative radiotherapy. Cancer 94 (2002) 1121-1130
21. Dworak O., Keilholz L., and Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 12 (1997) 19-23
22. Wheeler J.M., Warren B.F., Mortensen N.J., et al. Quantification of histologic regression of rectal cancer after irradiation: A proposal for a modified staging system. Dis Colon Rectum 45 (2002) 1051-1056
23. Carraro S., Roca E.L., Cartelli C., et al. Radiochemotherapy with short daily infusion of low-dose oxaliplatin, leucovorin, and 5-FU in T3-T4 unresectable rectal cancer: A phase II IATTGI study. Int J Radiat Oncol Biol Phys 54 (2002) 397-402
24. Machiels J.P., Duck L., Honhon B., et al. Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: The RadiOxCape study. Ann Oncol 16 (2005) 1898-1905
25. Sebag-Montefiore D., Glynne-Jones R., Falk S., et al. A phase I/II study of oxaliplatin when added to 5-fluorouracil and leucovorin and pelvic radiation in locally advanced rectal cancer: A Colorectal Clinical Oncology Group (CCOG) study. Br J Cancer 93 (2005) 993-998
26. Gérard J.P., Chapet O., Nemoz C., et al. Preoperative concurrent chemoradiotherapy in locally advanced rectal cancer with high-dose radiation and oxaliplatin-containing regimen: The Lyon R0-04 phase II trial. J Clin Oncol 21 (2003) 1119-1124