Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer

NCT ID: NCT01665274

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2022-09-30

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XELOX adjuvant group

D2 resection

XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Capecitabine 1,000 mg/m² twice daily, d1-14, q3w

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin IV infusion, 130mg/m² d1, q3w

D2 resection

Intervention Type: PROCEDURE

D2 resection

XELOX neoadjuvant

XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.

D2 resection

After operation:

CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Capecitabine 1,000 mg/m² twice daily, d1-14, q3w

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin IV infusion, 130mg/m² d1, q3w

D2 resection

Intervention Type: PROCEDURE

D2 resection

Interventions

Capecitabine

Capecitabine 1,000 mg/m² twice daily, d1-14, q3w

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin IV infusion, 130mg/m² d1, q3w

Intervention Type: DRUG

D2 resection

D2 resection

Intervention Type: PROCEDURE

Other Intervention Names

xeloda; eloxatin

Eligibility Criteria

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 ≥1·5×10⁹/L and platelet count ≥100×10⁹/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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yingwei Xue

Chief of Gastrointestinal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingwei Xue, Phd, MD

Role: STUDY_DIRECTOR

Harbin Medical University

Locations

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Countries

China

Other Identifiers

GCPCT1205/repeat

Identifier Type: -

Identifier Source: org_study_id