[Phase I study of postoperative concurrent chemoradiation with capecitabine as adjuvant treatment for stage II/III operable rectal cancer].
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Jin
Jing
J
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Li
Ye-Xiong
YX
Liu
Yue-Ping
YP
Wang
Wei-Hu
WH
Li
Tao
T
Li
Ning
N
Song
Yong-wen
YW
D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011182:Postoperative Care; D018714:Radiotherapy, Adjuvant; D020266:Radiotherapy, Conformal; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D012007:Rectum / Q000601:surgery
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil