Phase I study of postoperative concurrent chemoradiation with capecitabine as adjuvant treatment for stage II/III operable rectal cancer / 中华肿瘤杂志
Chinese Journal of Oncology
; (12): 393-396, 2006.
Article
in Zh
| WPRIM
| ID: wpr-236956
Responsible library:
WPRO
ABSTRACT
<p><b>OBJECTIVE</b>This phase I study is to determine the maximal tolerated dose and the dose-limiting toxicity of capecitabine combined with standard radiotherapy (RT) as postoperative adjuvant treatment for rectal cancer patients.</p><p><b>METHODS</b>Stage II/III rectal cancer patients 18 - 75 years of age had undergone curative surgery with Karnofsky score > or = 70% were eligible to be included in this study. Total dose of RT DT 50 Gy was delivered to the pelvic area in fraction of 2.0 Gy per day for 5 weeks. Capecitabine was orally administered concurrently with radiotherapy for a total of 2 cycles in escalating doses twice daily at 12 hour interval for consecutive 14 days as one cycle, separated by a seven day rest, then followed by another cycle. From March 2004 to May 2005, 24 patients were included and treated at the following dose levels daily 1000 mg/m(2) (3 patients), 1200 mg/m(2) (3 patients), 1400 mg/m(2) (3 patients), 1500 mg/m(2) (3 patients), 1600 mg/m(2) (6 patients), and 1700 mg/m(2) (6 patients). Dose-limiting toxicities (DLT) including grade 3 or grade 4 hematologic and nonhematologic toxicity were observed.</p><p><b>RESULTS</b>Dose-limiting toxicity was observed in one patient treated at dose of 1600 mg/m(2) with grade 3 diarrhea, and in 2 patients at dose of 1700 mg/m(2) with one grade 3 and one grade 4 diarrhea.</p><p><b>CONCLUSION</b>Diarrhea is the most common dose-limiting toxicity. In our study, the maximal tolerated dose (MTD) of capecitabine given concurrently with radiotherapy was daily 1600 mg/m(2), from D1 to D14 separated by 7-day rest for 2 cycles. Capecitabine given concurrently with standard radiotherapy is safe and tolerable for operated stage II/III rectal cancer patients.</p>
Full text:
1
Index:
WPRIM
Main subject:
Pathology
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Postoperative Care
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Radiotherapy
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Rectal Neoplasms
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Rectum
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General Surgery
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Drug Administration Schedule
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Chemotherapy, Adjuvant
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Radiotherapy, Adjuvant
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Radiotherapy, Conformal
Limits:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
Language:
Zh
Journal:
Chinese Journal of Oncology
Year:
2006
Type:
Article