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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00961077
• Other study ID #: SCH-HO-GC-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 17, 2009
• Last updated: August 17, 2009
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2009
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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)…

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly
• First-Line
• Gastric Cancer
• Oxaliplatin
• S-1
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC		every 2 cycles	No
Secondary	To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen		every 2 months	Yes