Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
number of patients suffering dose limited toxicity
more than 1/3 patients suffer DLT means the end of the trial.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
up to 7 weeks from start of the treatment
Jing Jin, Ph.D.
Chinese Academic Medical Science
China: Food and Drug Administration