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

NCT ID: NCT02071043

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-01-31

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XELOX

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

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Interventions

Capecitabine

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tianshu Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Medicine-Oncology Derpartment of Zhongshan hospital

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ZS-ON-03

Identifier Type: -

Identifier Source: org_study_id