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

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Capecitabine/cisplatin; Drug: Capecitabine; Drug: S-1/cisplatin; Drug: S-1; Drug: Capecitabine/oxaliplatin; Drug: 5-fluorouracil; Drug: 5-fluorouracil/oxaliplatin

• Registration Number: NCT02114359
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platinum/fluoropyrimidine combination chemotherapy	Capecitabine/oxaliplatin	-
Platinum/fluoropyrimidine combination chemotherapy	Capecitabine/cisplatin	-
Platinum/fluoropyrimidine combination chemotherapy	S-1/cisplatin	-
Platinum/fluoropyrimidine combination chemotherapy	5-fluorouracil/oxaliplatin	-
Fluoropyrimidine monochemotherapy	Capecitabine	-
Fluoropyrimidine monochemotherapy	S-1	-
Fluoropyrimidine monochemotherapy	5-fluorouracil	-

Primary Outcome Measures

Name	Time	Method
comparison of overall survival	upto 3years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Yeongnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

The Catholic University of Korea Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Inje University Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of