Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02114359

Enrollment

111

Registered

2014-04-15

Start date

2014-02-28

Completion date

2020-02-29

Last updated

2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, elderly, chemotherapy

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.

Interventions

DRUGCapecitabine/cisplatin

Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks

DRUGS-1/cisplatin

S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks

DRUGCapecitabine/oxaliplatin

Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks

DRUG5-fluorouracil/oxaliplatin

5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks

DRUGCapecitabine

Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 1000mg/m2 po bid)

DRUGS-1

S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 30mg/m2 po bid)

DRUG5-fluorouracil

5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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) * 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) * Life expectancy \> 3month * Written informed consent

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

Design outcomes

Primary

Measure	Time frame
comparison of overall survival	upto 3years

Secondary

Measure	Time frame
comparison of progression-free survival	upto 2years
comparison of response rate	upto 2years
comparison of adverse events	upto 2yrs
comparison of quality of life	upto 2years

Other

Measure	Time frame	Description
comprehensive geriatric assessment	baseline	The investigators are going to evaluate that comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance to treatment, survival of patients. Comprehensive geriatric assessment will not necessarily be tested in all subjects, but instead, screening tool (KG-7 (Korean screening tool for the elderly)) will be tested in all subjects.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026