Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

NCT01470742 | Withdrawn Phase 3

• 1 other identifier: 2010-04-118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)

  36months

Secondary Outcomes (1)

• response rate

  36months

Study Arms (2)

XELODA

ACTIVE COMPARATOR

Capecitabine 1000mg/m2 bid D1-14 every 3weeks

Drug: XELODA

XELOX

EXPERIMENTAL

D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks

Drug: XELOX

Interventions

XELOX DRUG

D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks

XELOX

XELODA DRUG

Capecitabine 1000mg/m2 bid D1-14 every 3weeks

XELODA

Eligibility Criteria

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

You may qualify if:

• Age ≥ 70
• Histologically or cytologically confirmed adenocarcinoma of the gastric
• Advanced ,metastatic/recurrence gastric cancer
• ECOG performance status of 0 to 2
• Life expectancy≥3months
• No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is \> 6months from the study entry date)
• No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
• Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
• Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
• Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT \< normal x 3)
• provision of a signed written informed consent

You may not qualify if:

• History of any medical or psychiatric condition
• Active infections
• Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 \>=Grade 1 )
• symptomatic brain metastases
• Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
• History of other malignancy except:
• Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
• Known hypersensitivity to Fluoropyrimidines/platinum
• Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
• Required immunosuppressive therapy(transplant patients, severe autoimmune disease)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

XELOX; Capecitabine

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 11, 2011
• Study Start: September 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

KR (1)