Overview

This trial is active, not recruiting.

Conditions elderly, s-1, oxaliplatin, first-line, gastric cancer
Treatment s-1 (ts-1) and oxaliplatin (oxalitin)
Phase phase 2
Sponsor Soonchunhyang University Hospital
Start date August 2009
End date August 2011
Trial size 36 participants
Trial identifier NCT00961077, SCH-HO-GC-01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
time frame: every 2 cycles

Secondary Outcomes

Measure
To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen
time frame: every 2 months

Eligibility Criteria

Male or female participants from 65 years up to 80 years old.

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)…

Additional Information

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
Principal investigator Sang-Cheol Lee, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Soonchunhyang University Hospital.