Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer

Phase 2

• Conditions: Elderly; S-1; Oxaliplatin; First-Line; Gastric Cancer

• Registration Number: NCT00961077
• Lead Sponsor: Soonchunhyang University Hospital

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

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.

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-17
• Last Update Submitted: 2009-08-17
• Study First Posted: 2009-08-18
• Last Update Posted: 2009-08-18
• Primary Completion: 2011-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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 Criteria

• 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)...

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC	every 2 cycles

Secondary Outcome Measures

Name	Time	Method
To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen	every 2 months