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

NCT02071043 | Completed Phase 2

• 1 other identifier: ZS-ON-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

neo-adjuvant chemotherapy; advanced gastric cancer patients; para-aortic lymph node metastasis

Outcome Measures

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

  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 Outcomes (3)

• progression-free survival (PFS)

  40 Months after the last subject participate in

• overall survival

  3 years after the last subject participate in

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

  1 year after the last subject finish the treatment

Study Arms (1)

XELOX

EXPERIMENTAL

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

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

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

XELOX

Oxaliplatin DRUG

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

XELOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Tianshu Liu, Doctor

  Medicine-Oncology Derpartment of Zhongshan hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 25, 2014
• Study Start: November 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

CN (1)