Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer

NCT01665274 | Terminated Phase 2 DMC

• 1 other identifier: GCPCT1205/repeat
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

xelox; advanced gastric cancer

Outcome Measures

Primary Outcomes (1)

• 3-year DFS

  3 years after surgery

Secondary Outcomes (4)

• adverse events

  From date of randomization until the end of the study, assessed up to 5 years

• response rate

  evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy

• R0 resection rate

  after the pathological examination of resected speciments ie within 1 month after the operation

• overall survival

  5 years after surgery

Study Arms (2)

XELOX adjuvant group

ACTIVE COMPARATOR

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

Drug: Capecitabine; Drug: Oxaliplatin; Procedure: D2 resection

XELOX neoadjuvant

EXPERIMENTAL

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.

Drug: Capecitabine; Drug: Oxaliplatin; Procedure: D2 resection

Interventions

Capecitabine DRUG

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

Also known as: xeloda

XELOX adjuvant group; XELOX neoadjuvant

Oxaliplatin DRUG

Oxaliplatin IV infusion, 130mg/m² d1, q3w

Also known as: eloxatin

XELOX adjuvant group; XELOX neoadjuvant

D2 resection PROCEDURE

D2 resection

XELOX adjuvant group; XELOX neoadjuvant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

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

• Yingwei Xue, Phd, MD

  Harbin Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastrointestinal Surgery

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 15, 2012
• Study Start: September 1, 2013
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

CN (1)