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

Sponsor
Samsung Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01470742
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
63
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Feb 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: XELODA

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

Drug: XELODA
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
Experimental: XELOX

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

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

Outcome Measures

Primary Outcome Measures

  1. Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) [36months]

Secondary Outcome Measures

  1. response rate [36months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Known hypersensitivity to Fluoropyrimidines/platinum

  2. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)

  3. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01470742
Other Study ID Numbers:
  • 2010-04-118
First Posted:
Nov 11, 2011
Last Update Posted:
Dec 30, 2019
Last Verified:
Dec 1, 2019
Additional relevant MeSH terms:
Stomach Neoplasms
Capecitabine

Study Results

No Results Posted as of Dec 30, 2019