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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01470742
First received: November 7, 2011
Last updated: April 30, 2015
Last verified: April 2015
  Purpose
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 Intervention Phase
Gastric Cancer
Drug: XELOX
Drug: XELODA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) [ Time Frame: 36months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 36months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   70 Years and older   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01470742

Locations
Korea, Republic of
Samsung medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

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     History of Changes
Other Study ID Numbers: 2010-04-118 
Study First Received: November 7, 2011
Last Updated: April 30, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 09, 2016