Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
A Prospective Phase II Study of Attenuated S-1 and Oxaliplatin(Attenuated SOX) as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. However, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. There is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. Therefore, this phase II trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin (attenuated SOX)in patients with elderly AGC
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2009
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 18, 2009
August 1, 2009
2 years
August 17, 2009
August 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
every 2 cycles
Secondary Outcomes (1)
To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen
every 2 months
Interventions
S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours every 3 weeks
Eligibility Criteria
You may qualify if:
- Age : more than 70 to 80 and ECOG PS 0-2
- Age : more than 65 to less than 70 and ECOG PS 2
- Histological or pathologically confirmed adenocarinoma
- Relapsed or metastatic adenocarcinoma of stomach
- No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment
- At least more than one measurable lesion on RECIST criteria
- No radiation history for the target lesion
- An estimated life expectancy of more than 3 months
- Ability for adequate oral intake
- Adequate BM function: defined as WBC≥4000/μL, ANC ≥1500/μL, PLT≥100,000/μL.
- Adequate renal function: defined as Creatinine \<1.5mg/dL.
- Adequate hepatic function: defined as total bilirubin \< 2.0mg/dL, SGOT/SGPT \< normal x 3.
- Written informed consent
You may not qualify if:
- Symptomatic brain metastasis or meningeal metastasis.
- Double primary cancer
- Medical history of other cancer within 5 years
- G-I bleeding or intestinal obstruction (other condition that can't have the oral intake)
- Hypersensitivity to the 5-FU or oxaliplatin
- Active infectious disease that need to treat systemically
- Serious medical or psychologic condition: newly developed AMI ( within 6Ms)…
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Cheol Lee, M.D.
Soonchunhyang University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
August 18, 2009
Record last verified: 2009-08