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

NCT00961077 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-08-18

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Soonchunhyang University Hospital

    lead OTHER

Principal Investigators

  • Sang-Cheol Lee, M.D. · Soonchunhyang University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-08-31
Completion
2012-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961077 on ClinicalTrials.gov