Radiation therapy oncology group 0247: A randomized phase II study of neoadjuvant capecitabine and irinotecan or capecitabine and oxaliplatin with concurrent radiotherapy for patients with locally advanced rectal cancer

International Journal of Radiation Oncology Biology Physics

Volumn 82, Issue 4, 2012, Pages 1367-1375

  Wong, Stuart J ^a   Winter, Kathryn ^b   Meropol, Neal J ^c   Anne, Pramila Rani ^d   Kachnic, Lisa ^e   Rashid, Asif ^f   Watson, James C ^g   Mitchell, Edith ^d   Pollock, Jondavid ^h   Lee, Robert Jeffrey ⁱ   Haddock, Michael ^j   Erickson, Beth A ^a   Willett, Christopher G ^k  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

^b RADIATION THERAPY ONCOLOGY GROUP   (United States)

^c UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^d THOMAS JEFFERSON UNIVERSITY   (United States)

^e BOSTON MEDICAL CENTER   (United States)

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

^g FOX CHASE CANCER CENTER   (United States)

^h WHEELING HOSPITAL   (United States)

ⁱ INTERMOUNTAIN MEDICAL CENTER   (United States)

^j MAYO CLINIC   (United States)

^k DUKE UNIVERSITY   (United States)

more..

Author keywords

Cancer; Chemotherapy; Neoadjuvant; Radiotherapy; Rectal

Indexed keywords

ADJUVANT CHEMOTHERAPY; AFTER-TREATMENT; CANCER; CAPECITABINE; GASTROINTESTINAL TOXICITIES; HEMATOLOGIC TOXICITY; IRINOTECAN; NEOADJUVANT; NEOADJUVANT CHEMORADIOTHERAPY; NONHEMATOLOGIC TOXICITY; OXALIPLATIN; PATHOLOGIC COMPLETE RESPONSE (PCR); PHASE II; RADIATION THERAPY ONCOLOGY GROUPS; RANDOMIZED TRIAL; RECTAL; RECTAL CANCER;

CHEMOTHERAPY; RADIOTHERAPY; SURGERY; TOXICITY;

DISEASES;

CAPECITABINE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ABDOMINAL PAIN; ADJUVANT CHEMORADIOTHERAPY; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; BLOOD TOXICITY; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURGERY; COLITIS; CONTINUOUS INFUSION; CONTROLLED STUDY; DEHYDRATION; DEPRESSION; DERMATITIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG TOLERABILITY; ENTERITIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HICCUP; HUMAN; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; INFECTION; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PAIN; PENILE PAIN; PHASE 2 CLINICAL TRIAL; PREOPERATIVE CARE; PRIORITY JOURNAL; PROCTALGIA; PROCTITIS; RADIATION DOSE FRACTIONATION; RANDOMIZED CONTROLLED TRIAL; RECTUM CANCER; SIDE EFFECT; SMALL INTESTINAL STRICTURE; TOOTH DISEASE; TREATMENT RESPONSE; VOMITING; XEROSTOMIA;

ADULT; AGED; ALGORITHMS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CHEMORADIOTHERAPY; CHEMOTHERAPY, ADJUVANT; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; RADIOTHERAPY DOSAGE; RECTAL NEOPLASMS;

EID: 84857921757     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2011.05.027     Document Type: Article

References (32)

1. A. Jemal, R. Siegel, and E. Ward Cancer statistics, 2009 CA Cancer J Clin 59 2009 225 249
2. J.F. Bosset, L. Collette, and G. Calais Chemotherapy with preoperative radiotherapy in rectal cancer N Engl J Med 355 2006 1114 1123
3. J.P. Gerard, T. Conroy, and F. Bonnetain Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: Results of FFCD 9203 J Clin Oncol 24 2006 4620 4625
4. M. Mohiuddin, K. Winter, and E. Mitchell Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group trial 0012 J Clin Oncol 24 2006 650 655
5. T.R. Fleming One-sample multiple testing procedure for phase II clinical trials Biometrics 38 1982 143 151
6. C. Clopper, and S. Pearson The use of confidence or fiducial limits illustrated in the case of the binomial Biometrika 26 1934 404
7. F. Stipa, D.B. Chessin, and J. Shia A pathologic complete response of rectal cancer to preoperative combined-modality therapy results in improved oncological outcome compared with those who achieve no downstaging on the basis of preoperative endorectal ultrasonography Ann Surg Oncol 13 2006 1047 1053
8. L. Collette, J.F. Bosset, and M. den Dulk Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: Does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group J Clin Oncol 25 2007 4379 4386
9. J. Garcia-Aguilar, E. Hernandez de Anda, and P. Sirivongs A pathologic complete response to preoperative chemoradiation is associated with lower local recurrence and improved survival in rectal cancer patients treated by mesorectal excision Dis Colon Rectum 46 2003 298 304
10. F.M. Vecchio, V. Valentini, and B.D. Minsky The relationship of pathologic tumor regression grade (TRG) and outcomes after preoperative therapy in rectal cancer Int J Radiat Oncol Biol Phys 62 2005 752 760
11. C. Capirci, V. Valentini, and L. Cionini Prognostic value of pathologic complete response after neoadjuvant therapy in locally advanced rectal cancer: Long-term analysis of 566 ypCR patients Int J Radiat Oncol Biol Phys 72 2008 99 107
12. J.F. Bosset, L. Collette, and G. Calais Chemotherapy with preoperative radiotherapy in rectal cancer N Engl J Med 355 2006 1114 1123
13. D.P. Korkolis, C.S. Boskos, and G.D. Plataniotis Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer Anticancer Res 27 2007 541 545
14. S. Krishnan, N.A. Janjan, and J.M. Skibber Phase II study of capecitabine (Xeloda) and concomitant boost radiotherapy in patients with locally advanced rectal cancer Int J Radiat Oncol Biol Phys 66 2006 762 771
15. S.P. Desai, B.F. El-Rayes, and E. Ben-Josef A phase II study of preoperative capecitabine and radiation therapy in patients with rectal cancer Am J Clin Oncol 30 2007 340 345
16. I. Craven, A. Crellin, and R. Cooper Preoperative radiotherapy combined with 5 days per week capecitabine chemotherapy in locally advanced rectal cancer Br J Cancer 97 2007 1333 1337
17. J.P. Gerard, D. Azria, and S. Gourgou-Bourgade Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: Results of the phase III trial ACCORD 12/0405-prodige 2 J Clin Oncol 28 2010 1638 1644
18. C. Rodel, G.G. Grabenbauer, and T. Papadopoulos Phase I/II trial of capecitabine, oxaliplatin, and radiation for rectal cancer J Clin Oncol 21 2003 3098 3104
19. C. Aschele, M.L. Friso, and S. Pucciarelli 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
20. D.P. Ryan, D. Niedzwiecki for the Cancer and Leukemia Group B 89901 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
21. Aschele C, Pinto C, Rosati G, et al. Pre-operative FU-based chemoradiation +/- weekly oxaliplatin in locally advanced rectal cancer: Preliminary safety findings of the STAR (studio terapia adiuvante retto)-01 randomized trial [Abstract 23]. Proceedings of the 2007 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, Orlando, FL, 2007.
22. J.E. Tepper, and A.Z. Wang Improving local control in rectal cancer: Radiation sensitizers or radiation dose? J Clin Oncol 28 2010 1623 1624
23. D.G. Haller, J. Cassidy, and S.J. Clarke Potential regional differences for the tolerability profiles of fluoropyrimidines J Clin Oncol 26 2008 2118 2123
24. B. Minsky, E. O'Reilly, and D. Wong Daily low-dose irinotecan (CPT-11) plus pelvic irradiation as preoperative treatment of locally advanced rectal cancer [Abstract 1023] J Clin Oncol 18 1999 266a
25. E.P. Mitchell, P.R. Anne, and R. Fry Chemoradiation with CPT-11, 5FU in neoadjuvant treatment of locally advanced or recurrent adenocarcinoma of the rectum: A phase I/II study update [Abstract 1052] Proc Am Soc Clin Oncol 22 2003 262
26. V.K. Mehta, C. Cho, and J.M. Ford 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 Int J Radiat Oncol Biol Phys 55 2003 132 137
27. J. Dunst, T. Reese, and T. Sutter Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer J Clin Oncol 20 2002 3983 3991
28. S. Ngan, J. Zalcberg, and A. Kell A phase I study of capecitabine combined with radiotherapy for locally advanced potentially operable rectal cancer Proc Am Soc Clin Oncol 20 2001 149a
29. A. Kennedy, D. Van Echo, and C. Volpe Phase I studies using capecitabine combined with conformal radiation therapy (RT), paclitaxel, CPT-11 and celecoxib in gastrointestinal malignancies [Abstract 3021] Proc Am Soc Clin Oncol 21 2002 (abstr 3021)
30. C. Aschele, M. Friso, and S. Pucciarelli A phase I-II study of weekly oxaliplatin (OXA), 5-fluorouracil (FU) continuous infusion (CI) and preoperative radiotherapy (RT) in locally advanced rectal cancer (LARC) [Abstract 527] Proc Am Soc Clin Oncol 21 2002 (abstr 527)
31. D. Rosenthal, P. Catalano, and D. Halle ECOG 1297: A phase I study of preoperative radiation therapy (RT) with concurrent protracted continuous infusion 5-FU an dose escalating oxaliplatin followed by surgery, adjuvant 5-FU, and leucovorin for locally advanced (T3/4) rectal adenocarcinoma [Abstract 1094] Proc Am Soc Clin Oncol 22 2003 273
32. F. Eric, Y. Marc, and D. Michel A phase I study of 5-fluorouracil continuous infusion (5FU CI), weekly oxaliplatin (OXA) and radiotherapy (RT) in advanced rectal cancer [Abstract 1381] Proc Am Soc Clin Oncol 22 2003 344