Status:
UNKNOWN
Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
Lead Sponsor:
Soonchunhyang University Hospital
Conditions:
Elderly
S-1
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
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-r...
Detailed Description
Treatment scheme * S-1 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours Each cycle is repeated every 3 weeks Response evaluation will be performed every 2 cycles Repeated cycl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)…
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00961077
Start Date
August 1 2009
End Date
August 1 2012
Last Update
August 18 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.