Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced disease, and only chemotherapy is recommended from the guidelines. In unresectable cases, neoadjuvant chemotherapy could prolong survival if conversion to resectability could be achieved.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Capecitabine 1000 mg/m2 ,orally taken 30 minutes after meal, bid , d 1\~14 every 3
Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The primary study end point was the response rate of preoperative XELOX followed by surgery in gastric cancer patients with PAN involvement
evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After surgery, CT scan will be planned every 3 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
Time frame: 8 Months after the last subject participate in
progression-free survival (PFS)
be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After surgery, CT scan will be planned every 3 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
Time frame: 40 Months after the last subject participate in
overall survival
out-patient clinic and telephone visit will be done every 3 months for the first two years, and every 6 months after two years
Time frame: 3 years after the last subject participate in
Grade 3 or 4 Adverse Events as a Measure of Safety
Adverse Events will measure in the whole study according to CTC-AE 4.0
Time frame: 1 year after the last subject finish the treatment
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