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

NCT ID: NCT00961077

Last Updated: 2009-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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)…

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soonchunhyang University Hospital

Principal Investigators

Sang-Cheol Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Other Identifiers

SCH-HO-GC-01

Identifier Type: -

Identifier Source: org_study_id