Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial

NCT00278863 | Completed Phase 2 Results

• 1 other identifier: AMC-ONCGI-0415
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 9

Brief Summary

A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.

Conditions

Gastric Cancer

Keywords

Stomach cancer; Palliative chemotherapy; Capecitabine; S-1

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR.

  Up to 2 years

Secondary Outcomes (1)

• Number of Patients With Adverse Events

  Up to 2 years

Study Arms (2)

S-1

ACTIVE COMPARATOR

Drug: S-1

Capecitabine

ACTIVE COMPARATOR

Drug: Capecitabine

Interventions

S-1 DRUG

S-1

Capecitabine DRUG

Capecitabine

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Pathologically proven gastric or gastroesophageal junction adenocarcinoma
• Metastatic or recurrent unresectable disease
• Measurable lesions (according to Response Evaluation Criteria in Solid Tumors \[RECIST\])
• Age: 65-85 years old
• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
• Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
• Adequate renal function (serum creatinine≤ 1.5)
• Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal \[UNL\], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
• No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient

You may not qualify if:

• Previous palliative chemotherapy
• Known allergy to study drugs
• CNS metastasis
• Significant medical comorbidities
• Active ongoing infection which antibiotic treatment is needed.
• Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (9)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Location

Hallym University Sacred Heart Hospital

Pyeongchon, Gyeonggido, South Korea

Location

Kyung Pook National University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Gacheon Medical School Gil Medical Center

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea Cancer Center Hospital

Seoul, South Korea

Location

Seoul Samsung Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Yoon-Koo Kang
• Organization: Asan Medical Center

ykkang@amc.seoul.kr

+82-2-3010-3210

Study Officials

• Yoon-Koo Kang, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: November 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: February 25, 2014
• Results First Posted: February 25, 2014

Record last verified: 2014-01

Locations

KR (9)