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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


Phase 2
65 Years
80 Years
Open (Enrolling)
Both
Elderly, S-1, Oxaliplatin, First-Line, Gastric Cancer

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Trial Information

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


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.


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)…

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC

Outcome Time Frame:

every 2 cycles

Safety Issue:

No

Principal Investigator

Sang-Cheol Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Soonchunhyang University Hospital

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

SCH-HO-GC-01

NCT ID:

NCT00961077

Start Date:

August 2009

Completion Date:

August 2012

Related Keywords:

  • Elderly
  • S-1
  • Oxaliplatin
  • First-Line
  • Gastric Cancer
  • elderly
  • S-1
  • Oxaliplatin
  • relapsed or metastatic gastric cancer
  • Stomach Neoplasms

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