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

Sponsor:	Soonchunhyang University Hospital
Information provided by:	Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:	NCT00961077

Purpose

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

Condition	Intervention	Phase
Elderly S-1 Oxaliplatin First-Line Gastric Cancer	Drug: S-1 (TS-1) and Oxaliplatin (Oxalitin)	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Oxaliplatin S 1 (Combination)

U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:

To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen [ Time Frame: every 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours

every 3 weeks

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.

Eligibility

Ages Eligible for Study:	65 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)…

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961077

Sponsors and Collaborators

Soonchunhyang University Hospital

Investigators

Principal Investigator:

Sang-Cheol Lee, M.D.

Soonchunhyang University Hospital

More Information

No publications provided

Responsible Party:	Jong-Ho Won, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:	NCT00961077 History of Changes
Other Study ID Numbers:	SCH-HO-GC-01
Study First Received:	August 17, 2009
Last Updated:	August 17, 2009
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Soonchunhyang University Hospital:

elderly
S-1
Oxaliplatin
relapsed or metastatic gastric cancer

Additional relevant MeSH terms:

Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases

Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012