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Title: Phase I Trial of Preoperative Hypofractionated Intensity-Modulated Radiotherapy with Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer

Abstract

Purpose: To determine the safety and efficacy of preoperative hypofractionated radiotherapy using intensity-modulated radiotherapy (IMRT) and an incorporated boost with concurrent capecitabine in patients with locally advanced rectal cancer. Methods and Materials: The eligibility criteria included adenocarcinoma of the rectum, T3-T4 and/or N1-N2 disease, performance status 0 or 1, and age {>=}18 years. Photon IMRT and an incorporated boost were used to treat the whole pelvis to 45 Gy and the gross tumor volume plus 2 cm to 55 Gy in 25 treatments within 5 weeks. The study was designed to escalate the dose to the gross tumor volume in 5-Gy increments in 3-patient cohorts. Capecitabine was given orally 825 mg/m{sup 2} twice daily for 7 days each week during RT. The primary endpoint was the maximal tolerated radiation dose, and the secondary endpoints were the pathologic response and quality of life. Results: Eight patients completed RT at the initial dose level of 55 Gy. The study was discontinued because of toxicity-six Grade 3 toxicities occurred in 3 (38%) of 8 patients. All patients went on to definitive surgical resection, and no patient had a pathologically complete response. Conclusion: This regimen, using hypofractionated RT with an incorporated boost, had unacceptablemore » toxicity despite using standard doses of capecitabine and IMRT. Additional research is needed to determine whether IMRT is able to reduce the side effects during and after pelvic RT with conventional dose fractionation.« less

Authors:
 [1];  [2];  [3];  [3];  [4];  [4];  [2];  [2];  [2];  [5];  [6];  [4]
  1. Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA (United States). E-mail: G_Freedman@FCCC.edu
  2. Department of Medical Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA (United States)
  3. Department of Surgical Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA (United States)
  4. Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA (United States)
  5. University of Pennsylvania School of Nursing, Philadelphia, PA (United States)
  6. Winship Cancer Institute, Atlanta, GA (United States)
Publication Date:
OSTI Identifier:
20951582
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 67; Journal Issue: 5; Other Information: DOI: 10.1016/j.ijrobp.2006.11.017; PII: S0360-3016(06)03497-3; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; FRACTIONATED IRRADIATION; PATIENTS; PELVIS; PHOTONS; RADIATION DOSES; RADIOTHERAPY; RECTUM; SAFETY STANDARDS; SIDE EFFECTS; SURGERY; TOXICITY

Citation Formats

Freedman, Gary M., Meropol, Neal J., Sigurdson, Elin R., Hoffman, John, Callahan, Elaine, Price, Robert, Cheng, Jonathan, Cohen, Steve, Lewis, Nancy, Watkins-Bruner, Deborah, Rogatko, Andre, and Konski, Andre. Phase I Trial of Preoperative Hypofractionated Intensity-Modulated Radiotherapy with Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.11.017.
Freedman, Gary M., Meropol, Neal J., Sigurdson, Elin R., Hoffman, John, Callahan, Elaine, Price, Robert, Cheng, Jonathan, Cohen, Steve, Lewis, Nancy, Watkins-Bruner, Deborah, Rogatko, Andre, & Konski, Andre. Phase I Trial of Preoperative Hypofractionated Intensity-Modulated Radiotherapy with Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer. United States. doi:10.1016/j.ijrobp.2006.11.017.
Freedman, Gary M., Meropol, Neal J., Sigurdson, Elin R., Hoffman, John, Callahan, Elaine, Price, Robert, Cheng, Jonathan, Cohen, Steve, Lewis, Nancy, Watkins-Bruner, Deborah, Rogatko, Andre, and Konski, Andre. Sun . "Phase I Trial of Preoperative Hypofractionated Intensity-Modulated Radiotherapy with Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer". United States. doi:10.1016/j.ijrobp.2006.11.017.
@article{osti_20951582,
title = {Phase I Trial of Preoperative Hypofractionated Intensity-Modulated Radiotherapy with Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer},
author = {Freedman, Gary M. and Meropol, Neal J. and Sigurdson, Elin R. and Hoffman, John and Callahan, Elaine and Price, Robert and Cheng, Jonathan and Cohen, Steve and Lewis, Nancy and Watkins-Bruner, Deborah and Rogatko, Andre and Konski, Andre},
abstractNote = {Purpose: To determine the safety and efficacy of preoperative hypofractionated radiotherapy using intensity-modulated radiotherapy (IMRT) and an incorporated boost with concurrent capecitabine in patients with locally advanced rectal cancer. Methods and Materials: The eligibility criteria included adenocarcinoma of the rectum, T3-T4 and/or N1-N2 disease, performance status 0 or 1, and age {>=}18 years. Photon IMRT and an incorporated boost were used to treat the whole pelvis to 45 Gy and the gross tumor volume plus 2 cm to 55 Gy in 25 treatments within 5 weeks. The study was designed to escalate the dose to the gross tumor volume in 5-Gy increments in 3-patient cohorts. Capecitabine was given orally 825 mg/m{sup 2} twice daily for 7 days each week during RT. The primary endpoint was the maximal tolerated radiation dose, and the secondary endpoints were the pathologic response and quality of life. Results: Eight patients completed RT at the initial dose level of 55 Gy. The study was discontinued because of toxicity-six Grade 3 toxicities occurred in 3 (38%) of 8 patients. All patients went on to definitive surgical resection, and no patient had a pathologically complete response. Conclusion: This regimen, using hypofractionated RT with an incorporated boost, had unacceptable toxicity despite using standard doses of capecitabine and IMRT. Additional research is needed to determine whether IMRT is able to reduce the side effects during and after pelvic RT with conventional dose fractionation.},
doi = {10.1016/j.ijrobp.2006.11.017},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 67,
place = {United States},
year = {Sun Apr 01 00:00:00 EDT 2007},
month = {Sun Apr 01 00:00:00 EDT 2007}
}