The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.
For those "younger" locally advanced (stage II/III) rectal cancer patients (usually means patients less than 70), it is suggested that after radical surgery, patients should receive concurrent chemo-radiation. Capecitabine is a widely used chemotherapy medicine under such condition. Based on experience, the investigators think this modality can also be tolerated by patients over 70, and will increase local control rate as which has been proved in younger ones. As the first step to test this hypothesis, we designed this phase I study to seek the proper dose of capecitabine, a widely used oral chemotherapy medicine, in postoperative concurrent chemo-radiation for stage II/III rectal cancer patients over 70, and to evaluate the safety of this modality in this group of patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
radiation department, Cancer Hospital, CAMS
Beijing, Beijing Municipality, China
Dose Related Toxicity
dose related toxicity is defined as follows:1. WBC damage \>= grade 3; granular cell decrease \>= grade 3; hemoglobin \>= grade 2; platelet \>= grade 2;SGPT/SGOT elevation \>= grade 2; ALP \>= grade 2; GGT \>= grade 2; Tbil \>= grade 2;renal function damage: BUN/Cr elevation \>= grade 2;Non-gradular cell decreased fever \>= grade 2;nausea/vomiting \>= grade 2; fatigue \>= grade 3; weight loss \>= grade 3;gastritis \>= grade 3; dairrea \>= grade 3; abdominal pain \>= grade 3; pancreatitis \>= grade 2; upper gastrointestinal bleeding \>= grade 2;other toxic reaction \>= grade 3;KPS \< 50 during the treatment
Time frame: up to 9 weeks
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oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.