Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study

Seoul National University Hospital14 sites in 1 country111 target enrollmentFebruary 2014

InterventionsCapecitabine/cisplatin S-1/cisplatin Capecitabine/oxaliplatin 5-fluorouracil/oxaliplatin Capecitabine S-1 5-fluorouracil

DrugsCapecitabine/cisplatin S-1/cisplatin Capecitabine/oxaliplatin 5-fluorouracil/oxaliplatin Capecitabine S-1 5-fluorouracil

Overview

Phase: Phase 3
Intervention: Capecitabine/cisplatin
Conditions: Gastric Cancer
Sponsor: Seoul National University Hospital
Enrollment: 111
Locations: 14
Primary Endpoint: comparison of overall survival
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

February 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

In Sil Choi

Clinical Associate Professor, Department of Internal Medicine

SMG-SNU Boramae Medical Center

Eligibility Criteria

Inclusion Criteria

•.Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
•70 yrs or older
•Eastern Cooperative Oncology Group 0-2
•Measurable or evaluable disease
•Adequate major organ functions
•Hb ≥ 9.0 g/dL
•White blood cell count ≥ 3000/μL
•Absolute Neutrophil Count (ANC) ≥ 1500/μL \[\*ANC = neutrophil segs ＋ neutrophil bands\]
•Platelet ≥ 100 × 103/ μL
•Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)

Exclusion Criteria

•Metastatic or recurrent stomach cancer other than adenocarcinoma
•HER-2 positive
•Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
•Radiation therapy within the previous 2wks
•Major surgery or trauma within the previous 4wks
•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)
•Uncontrolled brain metastasis
•Presence of other serious disease (cardiovascular, hepatic, infection etc.)
•Patients who participated in other clinical trials within the previous 30days
•Men of childbearing potential not willing to use effective means of contraception