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Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer

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Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer. / Rödel, Claus; Liersch, Torsten; Hermann, Robert Michael; Arnold, Dirk; Reese, Thomas; Hipp, Matthias; Fürst, Alois; Schwella, Nimrod; Bieker, Michael; Hellmich, Gunter; Ewald, Hermann; Haier, Jörg; Lordick, Florian; Flentje, Michael; Sülberg, Heiko; Hohenberger, Werner; Sauer, Rolf.

in: J CLIN ONCOL, Jahrgang 25, Nr. 1, 01.01.2007, S. 110-7.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Rödel, C, Liersch, T, Hermann, RM, Arnold, D, Reese, T, Hipp, M, Fürst, A, Schwella, N, Bieker, M, Hellmich, G, Ewald, H, Haier, J, Lordick, F, Flentje, M, Sülberg, H, Hohenberger, W & Sauer, R 2007, 'Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer', J CLIN ONCOL, Jg. 25, Nr. 1, S. 110-7. https://doi.org/10.1200/JCO.2006.08.3675

APA

Rödel, C., Liersch, T., Hermann, R. M., Arnold, D., Reese, T., Hipp, M., Fürst, A., Schwella, N., Bieker, M., Hellmich, G., Ewald, H., Haier, J., Lordick, F., Flentje, M., Sülberg, H., Hohenberger, W., & Sauer, R. (2007). Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer. J CLIN ONCOL, 25(1), 110-7. https://doi.org/10.1200/JCO.2006.08.3675

Vancouver

Rödel C, Liersch T, Hermann RM, Arnold D, Reese T, Hipp M et al. Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer. J CLIN ONCOL. 2007 Jan 1;25(1):110-7. https://doi.org/10.1200/JCO.2006.08.3675

Bibtex

@article{6fa6c709418c45e29d1ae2824c2c7df7,
title = "Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer",
abstract = "PURPOSE: To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.PATIENTS AND METHODS: One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.RESULTS: After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.CONCLUSION: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.",
keywords = "Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Chemotherapy, Adjuvant, Combined Modality Therapy, Deoxycytidine, Female, Fluorouracil, Humans, Male, Middle Aged, Organoplatinum Compounds, Rectal Neoplasms, Remission Induction, Treatment Outcome",
author = "Claus R{\"o}del and Torsten Liersch and Hermann, {Robert Michael} and Dirk Arnold and Thomas Reese and Matthias Hipp and Alois F{\"u}rst and Nimrod Schwella and Michael Bieker and Gunter Hellmich and Hermann Ewald and J{\"o}rg Haier and Florian Lordick and Michael Flentje and Heiko S{\"u}lberg and Werner Hohenberger and Rolf Sauer",
year = "2007",
month = jan,
day = "1",
doi = "10.1200/JCO.2006.08.3675",
language = "English",
volume = "25",
pages = "110--7",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "1",

}

RIS

TY - JOUR

T1 - Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer

AU - Rödel, Claus

AU - Liersch, Torsten

AU - Hermann, Robert Michael

AU - Arnold, Dirk

AU - Reese, Thomas

AU - Hipp, Matthias

AU - Fürst, Alois

AU - Schwella, Nimrod

AU - Bieker, Michael

AU - Hellmich, Gunter

AU - Ewald, Hermann

AU - Haier, Jörg

AU - Lordick, Florian

AU - Flentje, Michael

AU - Sülberg, Heiko

AU - Hohenberger, Werner

AU - Sauer, Rolf

PY - 2007/1/1

Y1 - 2007/1/1

N2 - PURPOSE: To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.PATIENTS AND METHODS: One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.RESULTS: After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.CONCLUSION: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.

AB - PURPOSE: To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.PATIENTS AND METHODS: One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.RESULTS: After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.CONCLUSION: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.

KW - Adult

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Capecitabine

KW - Chemotherapy, Adjuvant

KW - Combined Modality Therapy

KW - Deoxycytidine

KW - Female

KW - Fluorouracil

KW - Humans

KW - Male

KW - Middle Aged

KW - Organoplatinum Compounds

KW - Rectal Neoplasms

KW - Remission Induction

KW - Treatment Outcome

U2 - 10.1200/JCO.2006.08.3675

DO - 10.1200/JCO.2006.08.3675

M3 - SCORING: Journal article

C2 - 17194912

VL - 25

SP - 110

EP - 117

JO - J CLIN ONCOL

JF - J CLIN ONCOL

SN - 0732-183X

IS - 1

ER -