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

Phase 2

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT02071043
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-23
• Last Update Submitted: 2014-02-23
• Study First Posted: 2014-02-25
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XELOX	Oxaliplatin	XELOX: Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1\~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks
XELOX	Capecitabine	XELOX: Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1\~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks

Primary Outcome Measures

Name	Time	Method
The primary study end point was the response rate of preoperative XELOX followed by surgery in gastric cancer patients with PAN involvement	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 Outcome Measures

Name	Time	Method
Grade 3 or 4 Adverse Events as a Measure of Safety	1 year after the last subject finish the treatment	Adverse Events will measure in the whole study according to CTC-AE 4.0
progression-free survival (PFS)	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.
overall survival	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

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China