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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine/cisplatin
* Drug: S-1/cisplatin
* Drug: Capecitabine/oxaliplatin
* Drug: 5-fluorouracil/oxaliplatin
* Drug: Capecitabine
* Drug: S-1
* Drug: 5-fluorouracil


Participation Criteria
=================
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) 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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platinum/fluoropyrimidine combination chemotherapy<br> | Drug: Capecitabine/cisplatin<br>* 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<br>Drug: S-1/cisplatin<br>* 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<br>Drug: Capecitabine/oxaliplatin<br>* 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<br>Drug: 5-fluorouracil/oxaliplatin<br>* 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<br>|
| Active Comparator: Fluoropyrimidine monochemotherapy<br> | Drug: Capecitabine<br>* Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid)<br>Drug: S-1<br>* S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid)<br>Drug: 5-fluorouracil<br>* 5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of overall survival |  | upto 3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, elderly, chemotherapy