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Title: A Phase I study of concurrent radiotherapy and capecitabine as adjuvant treatment for operable rectal cancer

Abstract

Purpose: To determine the maximum tolerated dose and the dose-limiting toxicity of capecitabine with standard radiotherapy (RT) as adjuvant treatment in patients with rectal cancer. Methods and Materials: Patients with Stage II/III rectal cancer after surgery were eligible. Total RT dose was delivered as DT 50 Gy in fractions of 2.0 Gy/day for 5 weeks to the pelvic area. Capecitabine was administered concurrently with RT in escalating doses, twice daily with a 12-h interval, for two cycles of 14 days separated by a 7-day rest. Dose-limiting toxicity included Grade 3 or Grade 4 hematologic and nonhematologic toxicity. Results: Twenty-four patients were enrolled at the following dose levels: 1,000 (3 patients), 1,200 (3 patients), 1,400 (3 patients), 1,500 (3 patients), 1,600 (6 patients), and 1,700 mg/m{sup 2}/day (6 patients). Dose-limiting toxicity was observed in 1 patient at 1,600 mg/m{sup 2}/day (Grade 3 diarrhea) and in 2 patients at 1,700 mg/m{sup 2}/day (1 patient had Grade 3 and 1 Grade 4 diarrhea). Conclusion: The maximum tolerated dose (MTD) of capecitabine given concurrently with RT was 1,600 mg/m{sup 2}, daily from the 1st to the 14th day, with a 7-day rest, for two cycles.

Authors:
 [1];  [2];  [1];  [1];  [1];  [1];  [1];  [1];  [1]
  1. Department of Radiation Oncology, Cancer Hospital/Institute, Peking Union Medical College, Beijing (China) and Chinese Academy of Medical Sciences, Beijing (China)
  2. Department of Radiation Oncology, Cancer Hospital/Institute, Peking Union Medical College, Beijing (China) and Chinese Academy of Medical Sciences, Beijing (China). E-mail: yexiong@yahoo.com
Publication Date:
OSTI Identifier:
20793337
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 64; Journal Issue: 3; Other Information: DOI: 10.1016/j.ijrobp.2005.08.017; PII: S0360-3016(05)02384-9; Copyright (c) 2006 Elsevier Science B.V., Amsterdam, The 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; COMBINED THERAPY; DIARRHEA; NEOPLASMS; PATIENTS; RADIATION DOSES; RADIOTHERAPY; SURGERY; TOXICITY

Citation Formats

Jin Jing, Li Yexiong, Liu Yueping, Wang Weihu, Song Yongwen, Li Tao, Li Ning, Yu Zihao, and Liu Xinfan. A Phase I study of concurrent radiotherapy and capecitabine as adjuvant treatment for operable rectal cancer. United States: N. p., 2006. Web. doi:10.1016/J.IJROBP.2005.0.
Jin Jing, Li Yexiong, Liu Yueping, Wang Weihu, Song Yongwen, Li Tao, Li Ning, Yu Zihao, & Liu Xinfan. A Phase I study of concurrent radiotherapy and capecitabine as adjuvant treatment for operable rectal cancer. United States. doi:10.1016/J.IJROBP.2005.0.
Jin Jing, Li Yexiong, Liu Yueping, Wang Weihu, Song Yongwen, Li Tao, Li Ning, Yu Zihao, and Liu Xinfan. Wed . "A Phase I study of concurrent radiotherapy and capecitabine as adjuvant treatment for operable rectal cancer". United States. doi:10.1016/J.IJROBP.2005.0.
@article{osti_20793337,
title = {A Phase I study of concurrent radiotherapy and capecitabine as adjuvant treatment for operable rectal cancer},
author = {Jin Jing and Li Yexiong and Liu Yueping and Wang Weihu and Song Yongwen and Li Tao and Li Ning and Yu Zihao and Liu Xinfan},
abstractNote = {Purpose: To determine the maximum tolerated dose and the dose-limiting toxicity of capecitabine with standard radiotherapy (RT) as adjuvant treatment in patients with rectal cancer. Methods and Materials: Patients with Stage II/III rectal cancer after surgery were eligible. Total RT dose was delivered as DT 50 Gy in fractions of 2.0 Gy/day for 5 weeks to the pelvic area. Capecitabine was administered concurrently with RT in escalating doses, twice daily with a 12-h interval, for two cycles of 14 days separated by a 7-day rest. Dose-limiting toxicity included Grade 3 or Grade 4 hematologic and nonhematologic toxicity. Results: Twenty-four patients were enrolled at the following dose levels: 1,000 (3 patients), 1,200 (3 patients), 1,400 (3 patients), 1,500 (3 patients), 1,600 (6 patients), and 1,700 mg/m{sup 2}/day (6 patients). Dose-limiting toxicity was observed in 1 patient at 1,600 mg/m{sup 2}/day (Grade 3 diarrhea) and in 2 patients at 1,700 mg/m{sup 2}/day (1 patient had Grade 3 and 1 Grade 4 diarrhea). Conclusion: The maximum tolerated dose (MTD) of capecitabine given concurrently with RT was 1,600 mg/m{sup 2}, daily from the 1st to the 14th day, with a 7-day rest, for two cycles.},
doi = {10.1016/J.IJROBP.2005.0},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 3,
volume = 64,
place = {United States},
year = {Wed Mar 01 00:00:00 EST 2006},
month = {Wed Mar 01 00:00:00 EST 2006}
}