+ Site Statistics
References:
54,258,434
Abstracts:
29,560,870
PMIDs:
28,072,757
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Four-week neoadjuvant intensity-modulated radiation therapy with concurrent capecitabine and oxaliplatin in locally advanced rectal cancer patients: a validation phase II trial



Four-week neoadjuvant intensity-modulated radiation therapy with concurrent capecitabine and oxaliplatin in locally advanced rectal cancer patients: a validation phase II trial



International Journal of Radiation Oncology, Biology, Physics 83(2): 587-593



To validate tolerance and pathological complete response rate (pCR) of a 4-week preoperative course of intensity-modulated radiation therapy (IMRT) with concurrent capecitabine and oxaliplatin (CAPOX) in patients with locally advanced rectal cancer. Patients with T3 to T4 and/or N+ rectal cancer received preoperative IMRT (47.5 Gy in 19 fractions) with concurrent capecitabine (825 mg/m(2) b.i.d., Monday to Friday) and oxaliplatin (60 mg/m(2) on Days 1, 8, and 15). Surgery was scheduled 4 to 6 weeks after the completion of chemoradiation. Primary end points were toxicity and pathological response rate. Local control (LC), disease-free survival (DFS), and overall survival (OS) were also analyzed. A total of 100 patients were evaluated. Grade 1 to 2 proctitis was observed in 73 patients (73%). Grade 3 diarrhea occurred in 9% of the patients. Grade 3 proctitis in 18% of the first 50 patients led to reduction of the dose per fraction to 47.5 Gy in 20 treatments. The rate of Grade 3 proctitis decreased to 4% thereafter (odds ratio, 0.27). A total of 99 patients underwent surgery. A pCR was observed in 13% of the patients, major response (96-100% of histological response) in 48%, and pN downstaging in 78%. An R0 resection was performed in 97% of the patients. After a median follow-up of 55 months, the LC, DFS, and OS rates were 100%, 84%, and 87%, respectively. Preoperative CAPOX-IMRT therapy (47.5 Gy in 20 fractions) is feasible and safe, and produces major pathological responses in approximately 50% of patients.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 053292136

Download citation: RISBibTeXText

PMID: 22079731

DOI: 10.1016/j.ijrobp.2011.06.2008


Related references

Phase I-II trial of concurrent capecitabine and oxaliplatin with preoperative intensity-modulated radiotherapy in patients with locally advanced rectal cancer. International Journal of Radiation Oncology, Biology, Physics 71(3): 748-755, 2008

Efficacy endpoints of radiation therapy group protocol 0247: a randomized, phase 2 study of neoadjuvant radiation therapy plus concurrent capecitabine and irinotecan or capecitabine and oxaliplatin for patients with locally advanced rectal cancer. International Journal of Radiation Oncology, Biology, Physics 91(1): 116-123, 2015

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 82(4): 1367-1375, 2012

RTOG 0247: A randomized phase II study of neoadjuvant capecitabine and irinotecan versus capecitabine and oxaliplatin with concurrent radiation therapy for locally advanced rectal cancer. Journal of Clinical Oncology 26(15_Suppl): 4021-4021, 2016

NRG Oncology Radiation Therapy Oncology Group 0822: A Phase 2 Study of Preoperative Chemoradiation Therapy Using Intensity Modulated Radiation Therapy in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer. International Journal of Radiation Oncology, Biology, Physics 93(1): 29-36, 2015

Preliminary results of a phase II neoadjuvant trial with gemcitabine/oxaliplatin and cetuximab followed by surgery or concurrent intensity modulated radiation therapy (IMRT) with capecitabine for patients with borderline resectable and unresectable nonmetastatic pancreatic cancer. Journal of Clinical Oncology 26(15_Suppl): 15506-15506, 2016

Neoadjuvant sandwich treatment with oxaliplatin and capecitabine administered prior to, concurrently with, and following radiation therapy in locally advanced rectal cancer: a prospective phase 2 trial. International Journal of Radiation Oncology, Biology, Physics 90(5): 1153-1160, 2015

Phase 2 Trial of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: ECOG 3204. International Journal of Radiation Oncology*biology*physics 93(3): S126-S127, 2015

Phase I trial of preoperative hypofractionated intensity modulated radiation therapy (IMRT) with incorporated boost and oral capecitabine in locally advanced rectal cancer (vol 67, pg 651, 2007). International Journal of Radiation Oncology Biology Physics 69(1): 320, 2007

Phase II Trial of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: 5-Year Clinical Outcomes ECOG-ACRIN Cancer Research Group E3204. Oncologist 20(6): 615-616, 2016

Phase II trial of preoperative radiochemotherapy with concurrent bevacizumab, capecitabine and oxaliplatin in patients with locally advanced rectal cancer. Radiation Oncology 8: 90, 2015

Efficacy and safety of neoadjuvant intensity-modulated radiotherapy with concurrent capecitabine for locally advanced rectal cancer. Diseases of the Colon and Rectum 58(2): 186-192, 2015

Phase I trial of preoperative cetuximab in combination with oxaliplatin, capecitabine, and radiation therapy for locally advanced rectal cancer. Journal of Clinical Oncology 26(15_Suppl): 15019-15019, 2016

Pre-operative bevacizumab, capecitabine, oxaliplatin and radiation among patients with locally advanced or low rectal cancer: a phase II trial. European Journal of Cancer 48(1): 37-45, 2012

Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: ECOG 3204. International Journal of Radiation Oncology*biology*physics 84(3): S144-S145, 2012