Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
up to 9 weeks
Yes
Jing Jin, Ph.D.
Principal Investigator
radiation department, cancer hospital, CAMS
China: Food and Drug Administration
CH-GI-013
NCT01268943
November 2010
December 2014
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