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

Advanced Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071043
• Other study ID #: ZS-ON-03
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2014
• Last updated: February 23, 2014
• Start date: November 2008
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine
Capecitabine 1000 mg/m2 ,orally taken 30 minutes after meal, bid , d 1~14 every 3
• Oxaliplatin
Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 Months after the last subject participate in
Secondary	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.	40 Months after the last subject participate in
Secondary	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	3 years after the last subject participate in
Secondary	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	1 year after the last subject finish the treatment