Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer (repeat)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Harbin Medical University
Sponsor:
Information provided by (Responsible Party):
Yingwei Xue, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01665274
First received: August 5, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Capecitabine
Drug: Oxaliplatin
Procedure: D2 resection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • 3-year DFS [ Time Frame: 3 years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: From date of randomization until the end of the study, assessed up to 5 years ] [ Designated as safety issue: Yes ]
  • response rate [ Time Frame: evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy ] [ Designated as safety issue: No ]
  • R0 resection rate [ Time Frame: after the pathological examination of resected speciments ie within 1 month after the operation ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 5 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

Drug: Capecitabine
Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
Other Name: xeloda
Drug: Oxaliplatin
Oxaliplatin IV infusion, 130mg/m² d1, q3w
Other Name: eloxatin
Procedure: D2 resection
D2 resection
Other Name: D2 resection
Experimental: 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.

Drug: Capecitabine
Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
Other Name: xeloda
Drug: Oxaliplatin
Oxaliplatin IV infusion, 130mg/m² d1, q3w
Other Name: eloxatin
Procedure: D2 resection
D2 resection
Other Name: D2 resection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665274

Contacts
Contact: Yingwei Xue, Phd, MD xyw801@163.com

Locations
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Ha er Bin, Heilongjiang, China
Contact: Yingwei Xue, Phd, MD       xyw801@163.com   
Sponsors and Collaborators
Harbin Medical University
Investigators
Study Director: Yingwei Xue, Phd, MD Harbin Medical University
  More Information

No publications provided

Responsible Party: Yingwei Xue, Chief of Gastrointestinal Surgery, Harbin Medical University
ClinicalTrials.gov Identifier: NCT01665274     History of Changes
Other Study ID Numbers: GCPCT1205/repeat
Study First Received: August 5, 2012
Last Updated: December 19, 2013
Health Authority: China: Ethics Committee

Keywords provided by Harbin Medical University:
xelox
advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014