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

August 17, 2009 updated by: Soonchunhyang University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen
Time Frame: every 2 months
every 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

  • Principal Investigator: Sang-Cheol Lee, M.D., Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ANTICIPATED)

August 1, 2011

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (ESTIMATE)

August 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH-HO-GC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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