Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO My JCO Subscriptions Customer Service Site Map

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Rödel, C.
Right arrow Articles by Sauer, R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Rödel, C.
Right arrow Articles by Sauer, R.
Journal of Clinical Oncology, Vol 21, Issue 16 (August), 2003: 3098-3104
© 2003 American Society for Clinical Oncology

Phase I/II Trial of Capecitabine, Oxaliplatin, and Radiation for Rectal Cancer

Claus Rödel, Gerhard. G. Grabenbauer, Thomas Papadopoulos, Werner Hohenberger, Hans-Joachim Schmoll, Rolf Sauer

From the Departments of Radiation Therapy and Surgery and Institute of Pathology, University of Erlangen, Erlangen; and Department of Internal Medicine and Hematology/Oncology, University of Halle-Wittenberg, Halle, Germany.

Address reprint requests to Claus Rödel, MD, Department of Radiotherapy, University of Erlangen, Universitätsstr 27, 91054 Erlangen, Germany; email: claus.roedel{at}strahlen.med.uni-erlangen.de.

Purpose: The purpose of this study was to establish the feasibility and efficacy of preoperative radiotherapy (RT) with concurrent capecitabine and oxaliplatin (XELOX-RT) in patients with rectal cancer.

Patients and Methods: Thirty-two patients with locally advanced (T3/T4) or low-lying rectal cancer received preoperative RT (total dose, 50.4 Gy). Capecitabine was administered concurrently at 825 mg/m2 bid on days 1 to 14 and 22 to 35, with oxaliplatin starting at 50 mg/m2 on days 1, 8, 22, and 29 with planned escalation steps of 10 mg/m2. End points of the phase II study included downstaging, histopathologic tumor regression, resectability of T4 disease, and sphincter preservation in patients with low-lying tumors.

Results: Dose-limiting grade 3 gastrointestinal toxicity was observed in two of six patients treated with 60 mg/m2 of oxaliplatin. Thus, 50 mg/m2 was the recommended dose for the phase II study. Toxicities observed at this dose level were generally mild, with only two cases of short-lived grade 3 diarrhea. Myelosuppression, mainly leukopenia, was restricted to grade 2 in 19% of patients. T-category downstaging was achieved in 17 (55%) of 31 operated patients, and 68% of patients had negative lymph nodes. Pathologic complete response was found in 19% of the resected specimens. Radical surgery with free margins could be performed in 79% of patients with T4 disease, and 36% of patients with tumors <= 2 cm from the dentate line had sphincter-saving surgery.

Conclusion: Preoperative XELOX-RT is a feasible and well tolerated treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based therapy with XELOX chemoradiotherapy.

Supported in part by a grant from Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany, and Sanofi-Synthelabo GmbH, Berlin, Germany.




This article has been cited by other articles:


Home page
 Am Soc Clin Oncol Ed BookHome page
C. Rodel
Radiation Therapy Combined with Novel Chemotherapy Regiments and Targeted Agents for Patients with Rectal Cancer
ASCO Educational Book, January 1, 2008; 2008(1): 146 - 151.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
C. G. Willett, B. G. Czito, and J. C. Bendell
Radiation Therapy in Stage II and III Rectal Cancer
Clin. Cancer Res., November 15, 2007; 13(22): 6903s - 6908s.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
A. B. Benson III
New Approaches to Assessing and Treating Early-Stage Colon and Rectal Cancers: Cooperative Group Strategies for Assessing Optimal Approaches in Early-Stage Disease
Clin. Cancer Res., November 15, 2007; 13(22): 6913s - 6920s.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
C. Aschele and S. Lonardi
Multidisciplinary treatment of rectal cancer: medical oncology.
Ann. Onc., November 1, 2007; 18(11): 1908 - 1915.
[Full Text] [PDF]

Home page
 Ann. Surg. Oncol.Home page
G. A. Hospers, C. J. A. Punt, M. E. Tesselaar, A. Cats, K. Havenga, J. W. H. Leer, C. A. Marijnen, E. P. Jansen, H. H. J. M. Van Krieken, T. Wiggers, et al.
Preoperative Chemoradiotherapy with Capecitabine and Oxaliplatin in Locally Advanced Rectal Cancer. A Phase I II Multicenter Study of the Dutch Colorectal Cancer Group
Ann. Surg. Oncol., October 1, 2007; 14(10): 2773 - 2779.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
J-P Machiels, C Sempoux, P Scalliet, J-C Coche, Y Humblet, E Van Cutsem, J Kerger, J-L Canon, M Peeters, S Aydin, et al.
Phase I/II study of preoperative cetuximab, capecitabine, and external beam radiotherapy in patients with rectal cancer
Ann. Onc., April 1, 2007; 18(4): 738 - 744.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. Rodel, T. Liersch, R. M. Hermann, D. Arnold, T. Reese, M. Hipp, A. Furst, N. Schwella, M. Bieker, G. Hellmich, et al.
Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer
J. Clin. Oncol., January 1, 2007; 25(1): 110 - 117.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
J.-P. Gerard, T. Conroy, F. Bonnetain, O. Bouche, O. Chapet, M.-T. Closon-Dejardin, M. Untereiner, B. Leduc, E. Francois, J. Maurel, et al.
Preoperative Radiotherapy With or Without Concurrent Fluorouracil and Leucovorin in T3-4 Rectal Cancers: Results of FFCD 9203
J. Clin. Oncol., October 1, 2006; 24(28): 4620 - 4625.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
R. Glynne-Jones and D. Sebag-Montefiore
Role of Neoadjuvant Chemotherapy in Rectal Cancer: Interpretation of the EXPERT Study
J. Clin. Oncol., October 1, 2006; 24(28): 4664 - 4665.
[Full Text] [PDF]

Home page
 JCOHome page
T. Liersch, C. Langer, B. M. Ghadimi, B. Kulle, D. E. Aust, G. B. Baretton, W. Schwabe, P. Hausler, H. Becker, and C. Jakob
Lymph Node Status and TS Gene Expression Are Prognostic Markers in Stage II/III Rectal Cancer After Neoadjuvant Fluorouracil-Based Chemoradiotherapy
J. Clin. Oncol., September 1, 2006; 24(25): 4062 - 4068.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
S. R. Smalley, J. K. Benedetti, S. K. Williamson, J. M. Robertson, N. C. Estes, T. Maher, B. Fisher, T. A. Rich, J. A. Martenson, J. W. Kugler, et al.
Phase III Trial of Fluorouracil-Based Chemotherapy Regimens Plus Radiotherapy in Postoperative Adjuvant Rectal Cancer: GI INT 0144
J. Clin. Oncol., August 1, 2006; 24(22): 3542 - 3547.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
F. A. Calvo, F. J. Serrano, J. A. Diaz-Gonzalez, M. Gomez-Espi, E. Lozano, R. Garcia, D. de la Mata, J. A. Arranz, P. Garcia-Alfonso, G. Perez-Manga, et al.
Improved incidence of pT0 downstaged surgical specimens in locally advanced rectal cancer (LARC) treated with induction oxaliplatin plus 5-fluorouracil and preoperative chemoradiation
Ann. Onc., July 1, 2006; 17(7): 1103 - 1110.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
C. Aschele, M. L. Friso, P. Del Bianco, and S. Pucciarelli
Reply to Letter to the Editor 'Weekly oxaliplatin and pre-operative radiotherapy as a new neoadjuvant therapy for locally advanced rectal cancer', by T. Watanabe et al. (Ann Oncol 2006; 17: 1173)
Ann. Onc., July 1, 2006; 17(7): 1173 - 1174.
[Full Text] [PDF]

Home page
 JCOHome page
D. P. Ryan, D. Niedzwiecki, D. Hollis, B. E. Mediema, S. Wadler, J. E. Tepper, R. M. Goldberg, and R. J. Mayer
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., June 1, 2006; 24(16): 2557 - 2562.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
R. Glynne-Jones, J. Dunst, and D. Sebag-Montefiore
The integration of oral capecitabine into chemoradiation regimens for locally advanced rectal cancer: how successful have we been?
Ann. Onc., March 1, 2006; 17(3): 361 - 371.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
I. Chau, G. Brown, D. Cunningham, D. Tait, A. Wotherspoon, A. R. Norman, N. Tebbutt, M. Hill, P. J. Ross, A. Massey, et al.
Neoadjuvant Capecitabine and Oxaliplatin Followed by Synchronous Chemoradiation and Total Mesorectal Excision in Magnetic Resonance Imaging-Defined Poor-Risk Rectal Cancer
J. Clin. Oncol., February 1, 2006; 24(4): 668 - 674.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
A. De Paoli, S. Chiara, G. Luppi, M. L. Friso, G. D. Beretta, S. Del Prete, L. Pasetto, M. Santantonio, E. Sarti, G. Mantello, et al.
Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study
Ann. Onc., February 1, 2006; 17(2): 246 - 251.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
R. Glynne-Jones, D. Sebag-Montefiore, T. S. Maughan, S. J. Falk, and A. C. McDonald
A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer
Ann. Onc., January 1, 2006; 17(1): 50 - 56.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
J.-P. Machiels, L. Duck, B. Honhon, B. Coster, J.-C. Coche, P. Scalliet, Y. Humblet, S. Aydin, J. Kerger, V. Remouchamps, et al.
Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study
Ann. Onc., December 1, 2005; 16(12): 1898 - 1905.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
M. J. O'Connell
Combined-Modality Neoadjuvant Therapy for Rectal Cancer
J. Clin. Oncol., August 20, 2005; 23(24): 5450 - 5451.
[Full Text] [PDF]

Home page
 Ann. Surg. Oncol.Home page
A. D. Cook, R. Single, and L. E. McCahill
Surgical Resection of Primary Tumors in Patients Who Present With Stage IV Colorectal Cancer: An Analysis of Surveillance, Epidemiology, and End Results Data, 1988 to 2000
Ann. Surg. Oncol., August 1, 2005; 12(8): 637 - 645.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
C. Aschele, M. L. Friso, S. Pucciarelli, S. Lonardi, L. Sartor, G. Fabris, E. D. L. Urso, P. Del Bianco, G. Sotti, M. Lise, et al.
A phase I-II study of weekly oxaliplatin, 5-fluorouracil continuous infusion and preoperative radiotherapy in locally advanced rectal cancer
Ann. Onc., July 1, 2005; 16(7): 1140 - 1146.
[Abstract] [Full Text] [PDF]

Home page
 Cancer Res.Home page
F. Rodel, J. Hoffmann, L. Distel, M. Herrmann, T. Noisternig, T. Papadopoulos, R. Sauer, and C. Rodel
Survivin as a Radioresistance Factor, and Prognostic and Therapeutic Target for Radiotherapy in Rectal Cancer
Cancer Res., June 1, 2005; 65(11): 4881 - 4887.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
B. M. Ghadimi, M. Grade, M. J. Difilippantonio, S. Varma, R. Simon, C. Montagna, L. Fuzesi, C. Langer, H. Becker, T. Liersch, et al.
Effectiveness of Gene Expression Profiling for Response Prediction of Rectal Adenocarcinomas to Preoperative Chemoradiotherapy
J. Clin. Oncol., March 20, 2005; 23(9): 1826 - 1838.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
R.-D. Hofheinz, B. von Gerstenberg-Helldorf, F. Wenz, U. Gnad, U. Kraus-Tiefenbacher, A. Muldner, R. Hehlmann, S. Post, A. Hochhaus, and F. Willeke
Phase I Trial of Capecitabine and Weekly Irinotecan in Combination With Radiotherapy for Neoadjuvant Therapy of Rectal Cancer
J. Clin. Oncol., March 1, 2005; 23(7): 1350 - 1357.
[Abstract] [Full Text] [PDF]

Home page
 NEJMHome page
R. Sauer, H. Becker, W. Hohenberger, C. Rodel, C. Wittekind, R. Fietkau, P. Martus, J. Tschmelitsch, E. Hager, C. F. Hess, et al.
Preoperative versus Postoperative Chemoradiotherapy for Rectal Cancer
N. Engl. J. Med., October 21, 2004; 351(17): 1731 - 1740.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
C. J. A. Punt
New options and old dilemmas in the treatment of patients with advanced colorectal cancer
Ann. Onc., October 1, 2004; 15(10): 1453 - 1459.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. Fernandez-Martos, J. Aparicio, C. Bosch, M. Torregrosa, J. M. Campos, S. Garcera, J. M. Vicent, I. Maestu, M. A. Climent, J. L. Mengual, et al.
Preoperative Uracil, Tegafur, and Concomitant Radiotherapy in Operable Rectal Cancer: A Phase II Multicenter Study With 3 Years' Follow-Up
J. Clin. Oncol., August 1, 2004; 22(15): 3016 - 3022.
[Abstract] [Full Text] [PDF]


About
JCO		 Editorial
Roster		 Advertising
Information		 Librarians &
Institutions		 Rights &
Permissions		 PDA Services

Copyright © 2003 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online