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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: 5-fluorouracil; Drug: S-1; Drug: 5-fluorouracil/oxaliplatin; Drug: Capecitabine/oxaliplatin; Drug: S-1/cisplatin; Drug: Capecitabine/cisplatin; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02114359

20140113/16-2014-9/021

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Platinum/fluoropyrimidine combination chemotherapy

Experimental group

Treatment:

Drug: S-1/cisplatin

Drug: Capecitabine/cisplatin

Drug: 5-fluorouracil/oxaliplatin

Drug: Capecitabine/oxaliplatin

Fluoropyrimidine monochemotherapy

Active Comparator group

Treatment:

Drug: Capecitabine

Drug: 5-fluorouracil

Drug: S-1