Clinical trial 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: neo-adjuvant chemotherapy
advanced gastric cancer patients
para-aortic lymph node metastasis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Gastric or gastroesophageal adenocarcinoma proven histologically .
2. 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))
3. Eastern Cooperative Oncology Group performance status of 0 to 1.
4. Life expectancy ≥12 weeks.
5. 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.
6. Female subjects should not be pregnant or breast-feeding.
7. No serious concomitant disease that will threaten the survival of patients to less than 5 years.

Exclusion Criteria:

1. 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.
2. 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.
3. Any other metastatic disease will render patient ineligible according to AJCC staging manual(such as liver，lung，etc）.
4. Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
5. 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.
6. Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
7. Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation)
8. 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 -

Primary outcomes:
measure: The primary study end point was the response rate of preoperative XELOX followed by surgery in gastric cancer patients with PAN involvement
timeFrame: 8 Months after the last subject participate in
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 40 Months after the last subject participate in
measure: overall survival
timeFrame: 3 years after the last subject participate in
measure: Grade 3 or 4 Adverse Events as a Measure of Safety
timeFrame: 1 year after the last subject finish the treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Medicine-Oncology Derpartment of Zhongshan hospital
name: Tianshu Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: