NCT00961077

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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

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 cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.

Conditions

• Elderly
• S-1
• Oxaliplatin
• First-Line
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	S-1 (TS-1) and Oxaliplatin (Oxalitin)	S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours every 3 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-08-01
• Completion: 2012-08-01
• First posted: 2009-08-18
• Last updated: 2009-08-18