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

NCT ID: NCT01470742

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XELODA

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

Group Type ACTIVE_COMPARATOR

XELODA

Intervention Type DRUG

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

XELOX

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

Group Type EXPERIMENTAL

XELOX

Intervention Type DRUG

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

Interventions

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XELOX

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

Intervention Type DRUG

XELODA

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 70
2. Histologically or cytologically confirmed adenocarcinoma of the gastric
3. Advanced ,metastatic/recurrence gastric cancer
4. ECOG performance status of 0 to 2
5. Life expectancy≥3months
6. 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)
7. 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.
8. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
9. Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
10. Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT \< normal x 3)
11. provision of a signed written informed consent

Exclusion Criteria

1. History of any medical or psychiatric condition
2. Active infections
3. Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 \>=Grade 1 )
4. symptomatic brain metastases
5. Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
6. History of other malignancy except:

Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
7. Known hypersensitivity to Fluoropyrimidines/platinum
8. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
9. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Ki Kang

Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2010-04-118

Identifier Type: -

Identifier Source: org_study_id