Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer

Gastric Cancer Clinical Trial

— repeat  

Official title:

A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01665274
• Other study ID #: GCPCT1205/repeat
• Status: Terminated
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: September 2022

Study information

• Verified date: September 2022
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate.

Description:

The patients of gastric cancer have been divided into two parts in random.The test group receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the same program after operation. The two groups have the same staging and eligibility criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate maybe the last evaluation standard.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2022
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Karnofsky performance status of =60 %.
• Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically, stage cT2-4N+M0, and cT4N0M0.
• Patients had to have adequate renal function (serum creatinine =1 times the upper limit of normal [ULN]), hepatic function (total bilirubin =1·5 times the ULN, aspartate or alanine aminotransferase =2·5 times the ULN, alkaline phosphatase =2·5 times the ULN, Serum albumin =30g/L), and haematological function (absolute neutrophil count =1·5×10?/L and platelet count =100×10?/L)

Exclusion Criteria:

• Pregnant or lactating women.
• According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including presence of tumor cells in the ascites).
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
• Has uncontrolled epilepsy, central nervous system diseases or mental disorders of history.
• Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
• Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
• Known peripheral neuropathy = CTCAEv3 grade 1 (Common Terminology for Adverse Events). Absence of deep tendon reflexes as the sole neurologic abnormality does not render the patient ineligible.
• Organ allografts requiring immunosuppressive therapy.
• Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
• Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN).
• Any of the following laboratory values:
• Absolute neutrophil count (ANC) < 1.5 x 109/L
• Platelet count < 100 x 109/L
• Total bilirubin > 1.5 x ULN
• ALAT, ASAT > 2.5 x ULN
• Alkaline phosphatase > 2.5 x ULN.
• Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
• Hypersensitivity to platinum compounds or any of the components of the study medications.
• Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine
Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
• Oxaliplatin
Oxaliplatin IV infusion, 130mg/m² d1, q3w

Procedure:
• D2 resection
D2 resection

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year DFS		3 years after surgery
Secondary	adverse events		From date of randomization until the end of the study, assessed up to 5 years
Secondary	response rate		evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy
Secondary	R0 resection rate		after the pathological examination of resected speciments ie within 1 month after the operation
Secondary	overall survival		5 years after surgery