This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.
It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility. Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out. The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
radiation department, Cancer Hospital, CAMS
Beijing, Beijing Municipality, China
Number of Participants Experienced Dose Limited Toxicity
Dose related toxicity is defined as follows:1. luecopenia \> grade 2; granular cell decrease \> grade 2; anemia \> grade 1; platelet \> grade 1;SGPT/SGOT elevation \> grade 1; ALP \> grade 1; GGT \> grade 1; Tbil \> grade 1;renal function damag \> grade 2;Non-gradular cell decreased fever \> grade 1;nausea/vomiting \> grade 1; fatigue \> grade 2; weight loss \> grade 2;gastritis \> grade 2; dairrea \> grade 2; abdominal pain \> grade 2; upper gastrointestinal bleeding \> grade 1;other toxic reaction \> grade 2;KPS \< 50 during the treatment
Time frame: up to 7 weeks from start of the treatment
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oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation