Comparison of efficacy and tolerance between combination therapy and monotherapy as a first line chemotherapy in elderly patient with advanced gastric cancer

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0001069
• Lead Sponsor: Seoul Metropolitan Government Seoul National University Boramae Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

(1)Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach
(2)Previously untreated pts, including patients with previous adjuvant chemotherapy completed more than 6 months
(3)70 yrs or older
(4)ECOG 0-2
(5)Measurable or evaluable disease
(6)Adequate major organ functions
-Hb = 9.0 g/dL
-WBC = 3000/µL
-ANC = 1500/µL [*ANC = neutrophil segs + neutrophil bands]
-platelet = 100 × 103/ µL
-total bilirubin = 1.5 ×UNL, AST/ALT = 3.0x UNL(in case of liver metastasis, AST/ALT = 5.0 x UNL)
-Serum creatinine = 1.5 × UNL (in case of serum creatinine > 1.5 mg/dL , Ccr should be >= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
(7)Life expectancy > 3month
(8)Written informed consent

Exclusion Criteria

(1) Metastatic or recurrent stomach cancer other than adenocarcinoma
(2)HER-2 positive
(3)Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
(4)Radiation therapy within the previous 2wks
(5)Major surgery or trauma within the previous 4wks
(6)Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
(7)Uncontrolled brain metastasis
(8)Presence of other serious disease (cardiovascular, hepatic, infection etc.)
(9)Patients who participated in other clinical trials within the previous 30days
(10) Men of childbearing potential not willing to use effective means of contraception
(11)Patients with cognifitive dysfunction who cannot understand and sign a informed consent form, and besides that, patients who are unsuitable for this clinical trial at physician's discretion

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OVERALL SURVIVA

Secondary Outcome Measures

Name	Time	Method
Progresion free survival, response rate;Safety;Quality of life;Geriatric assessment