Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00961077
Status:
UNKNOWN
Last Update Posted:
2009-08-18
First Post:
2009-08-17
Brief Title:
Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
A Prospective Phase II Study of Attenuated S-1 and OxaliplatinAttenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SOXin patients with elderly AGC
Detailed Description:
Treatment scheme
S-1 60mgm2day D1-14 Oxaliplatin 85mgm2 5DW 250mL MIV over 2-hours
Each cycle is repeated every 3 weeks
Response evaluation will be performed every 2 cycles
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity
S-1 60mgm2day D1-14 Oxaliplatin 85mgm2 5DW 250mL MIV over 2-hours
Each cycle is repeated every 3 weeks
Response evaluation will be performed every 2 cycles
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None