Comparison of efficacy and tolerance between combination therapy and monotherapy as a 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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001069

Enrollment

332

Registered

2014-04-16

Start date

2014-02-27

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Aarm: platinum/fluoropyrimidine combination chemotherapy (1) capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
OVERALL SURVIVAL	—

Secondary

Measure	Time frame
Progresion free survival, response rate;Safety;Quality of life;Geriatric assessment	—

Countries

Korea, Republic of

Contacts

Public ContactIN SIL CHOI

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Outcome results