Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, elderly, chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Capecitabine/cisplatin Type: Drug
Name: S-1/cisplatin Type: Drug
Name: Capecitabine/oxaliplatin Type: Drug
Name: 5-fluorouracil/oxaliplatin Type: Drug
Name: Capecitabine Type: Drug
Name: S-1 Type: Drug
Name: 5-fluorouracil Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
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
Locations
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Status: Recruiting
Contact: ZANG, M.D. - fhdzang@hallym.ac.kr
Chungbuk National University Hospital
Cheongju, Korea, Republic of
Status: Not yet recruiting
Contact: HAN, M.D.
Chonbuk National University Hospital
Chonju, Korea, Republic of
Status: Not yet recruiting
Contact: SONG, M.D.
Kyungpook National University Medical Center
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: KIM, M.D.
National Cancer Center
Goyang, Korea, Republic of
Status: Recruiting
Contact: PARK, M.D. - youngiee@dreamwiz.com
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Status: Not yet recruiting
Contact: SIM, M.D.
Inha University Hospital
Incheon, Korea, Republic of
Status: Not yet recruiting
Contact: LIM, M.D.
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Status: Not yet recruiting
Contact: KIM, M.D.
Pusan National University Hospital
Pusan, Korea, Republic of
Status: Not yet recruiting
Contact: SEOL, M.D.
Bundang Cha Hospital
Seongnam, Korea, Republic of
Status: Not yet recruiting
Contact: JUNG, M.D.
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Status: Recruiting
Contact: LEE, M.D. - hmodoctor@hanmail.net
Asan Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: RYU, M.D.
Gangnam Severance Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: CHO, M.D.
Korea University Guro Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: OH, M.D.
Kyung Hee University Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: MAENG, M.D.
Seoul National University Boramae Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: CHOI, M.D.
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: OH, M.D.
Start Date
February 2014
Completion Date
February 2017
Sponsors
Seoul National University Hospital
Source
Seoul National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page