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

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.

Conditions

• Gastric Cancer

Interventions

DRUG

Capecitabine/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

DRUG

S-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

DRUG

Capecitabine/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

DRUG

5-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

DRUG

Capecitabine

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

DRUG

S-1

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

DRUG

5-fluorouracil

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

Sponsors & Collaborators

• Ministry of Health & Welfare, Korea

  collaborator OTHER_GOV

• Korean Cancer Study Group

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• IN SIL CHOI, M.D., Ph.D. · SMG-SNU Boramae Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2020-02-29

Completion

2020-02-29

Countries

• South Korea

Study Locations