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

Sponsor

Soonchunhyang University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00961077

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Elderly S-1 Oxaliplatin First-Line Gastric Cancer	Drug: S-1 (TS-1) and Oxaliplatin (Oxalitin)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2012

Outcome Measures

Primary Outcome Measures

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

To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen [every 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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)…