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Completed

NCT Number: NCT02071043

Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gastric or gastroesophageal adenocarcinoma proven histologically .
  • Has para-aortic lymph node metastasis(PAN was defined as nodes in the region between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery (stations no. 16a2/16b1))
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Life expectancy ≥12 weeks.
  • Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).

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.

  • Female subjects should not be pregnant or breast-feeding.
  • No serious concomitant disease that will threaten the survival of patients to less than 5 years.

Exclusion criteria

  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • History of another malignancy in the last 5 years with the exception of the following:

Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer.

  • Any other metastatic disease will render patient ineligible according to AJCC staging manual(such as liver,lung,etc).
  • Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
  • Poorly controlled diabetes mellitus with fasting blood sugar > 18 mm. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
  • Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation)
  • Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated -

Treatment and study plan

Capecitabine

Drug

Capecitabine 1000 mg/m2 ,orally taken 30 minutes after meal, bid , d 1~14 every 3

Oxaliplatin

Drug

Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks

Primary outcomes

  1. The primary study end point was the response rate of preoperative XELOX followed by surgery in gastric cancer patients with PAN involvement

    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.

Secondary outcomes

  1. progression-free survival (PFS)

    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.

  2. overall survival

    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

  3. Grade 3 or 4 Adverse Events as a Measure of Safety

    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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 25, 2014
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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