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

Soon Chun Hyang University

Status and phase

Unknown

Phase 2

Conditions

First-Line

Gastric Cancer

Oxaliplatin

Elderly

S-1

Treatments

Drug: S-1 (TS-1) and Oxaliplatin (Oxalitin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00961077

SCH-HO-GC-01

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

65 to 80 years old

Volunteers

No 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 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)...