Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT02071043
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN , ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L。 Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
Exclusion criteria
Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer.
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
Time frame: 8 Months after the last subject participate in
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: 40 Months after the last subject participate in
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: 3 years after the last subject participate in
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: 1 year after the last subject finish the treatment
Adverse Events will measure in the whole study according to CTC-AE 4.0
Shanghai Zhongshan Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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