CompletedNCT00278863Updated Feb 25, 2014Results posted

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

A Phase 2 interventional study of S-1 and Capecitabine in Gastric Cancer, sponsored by Asan Medical Center. Completed at 9 sites in Korea, Republic of. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-02-25.

Sponsored by Asan Medical Center · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 65 Years to 85 Years
Sex: All

Study 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 studied

Gastric Cancer

Browse trials for

Stomach Neoplasms 2,851

Keywords

Stomach cancer
Palliative chemotherapy
Capecitabine
S-1

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 96 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 96 participants (actual)

Study arms

Active comparator
S-1
Drug: S-1
Active comparator
Capecitabine
Drug: Capecitabine

Interventions

DrugS-1
DrugCapecitabine

What researchers measure

Primary outcomes

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.
Time frame: Up to 2 years

Secondary outcomes

Number of Patients With Adverse Events
Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years
Time frame: Up to 2 years

Results

Posted Feb 25, 2014

Participant flow

Participant flow — Overall Study
Milestone	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
Started	49	47
Completed	44	45
Not completed	5	2

Outcome measures

PrimaryResponse 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.

Time frame:: Up to 2 years
Reported as:: Number · percentage of participants

Response Rate
percentage of participants	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
Response Rate	28.9 (15.6 to 42.1)	26.1 (13.4 to 38.8)

SecondaryNumber of Patients With Adverse Events

Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years

Time frame:: Up to 2 years
Reported as:: Number · participants

Number of Patients With Adverse Events
participants	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
Number of Patients With Adverse Events	42	44

Adverse events

Collected over Up to 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
S-1 for 2 Week on/1 Week Off	—	0/42 (0%)	42/42 (100%)
Capecitabine 2 Weeks on/1 Week Off	—	0/44 (0%)	44/44 (100%)

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
AnemiaBlood and lymphatic system disorders	37/42	39/44
AnorexiaGastrointestinal disorders	31/42	38/44
AstheniaGeneral disorders	34/42	34/44
Hand-foot syndromeSkin and subcutaneous tissue disorders	7/42	26/44
NauseaGastrointestinal disorders	23/42	22/44
StomatitisGastrointestinal disorders	9/42	24/44
Abdominal painGastrointestinal disorders	20/42	19/44
DiarrheaGastrointestinal disorders	13/42	16/44
LeukopeniaBlood and lymphatic system disorders	14/42	10/44
HyperbilirubinemiaHepatobiliary disorders	13/42	1/44

Baseline characteristics

Age, Customized
Age, Customized(years)	S-1 for 2 Weeks on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off	Total
Age_median	71 (65 to 82)	71 (66 to 88)	71 (65 to 88)

Sex: Female, Male
Sex: Female, Male(Participants)	S-1 for 2 Weeks on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off	Total
Female	8	16	24
Male	37	30	67

Region of Enrollment
Region of Enrollment(participants)	S-1 for 2 Weeks on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off	Total
Korea, Republic of	45	46	91

Study locations

9 sites

National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggido, Korea, Republic of
Kyung Pook National University Hospital
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Gacheon Medical School Gil Medical Center
Incheon, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Seoul Samsung Medical Center
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00278863
Lead sponsor: Asan Medical Center
Responsible party: Yoon-Koo Kang (Professor, Asan Medical Center) — Principal investigator
First posted: Jan 19, 2006
Start date: Nov 2004
Primary completion: Jan 2007
Completion: Jan 2007
Results posted: Feb 25, 2014
Last update: Feb 25, 2014

Study contacts

Yoon-Koo Kang, M.D., Ph.D.

principal investigator · Asan Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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