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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00278863
• Collaborator: (none)
• Enrollment: 96
• Locations: 9
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: S-1; Drug: Capecitabine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: S-1	Drug: S-1
Active Comparator: Capecitabine	Drug: Capecitabine

Outcome Measures

Primary Outcome Measures

1. Response Rate [Up to 2 years]

   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.

Secondary Outcome Measures

1. Number of Patients With Adverse Events [Up to 2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang	Gyeonggi-do	Korea, Republic of
2	Hallym University Sacred Heart Hospital	Pyeongchon	Gyeonggido	Korea, Republic of
3	Kyung Pook National University Hospital	Daegu		Korea, Republic of
4	Yeungnam University Medical Center	Daegu		Korea, Republic of
5	Gacheon Medical School Gil Medical Center	Incheon		Korea, Republic of
6	Asan Medical Center	Seoul		Korea, Republic of
7	Korea Cancer Center Hospital	Seoul		Korea, Republic of
8	Seoul Samsung Medical Center	Seoul		Korea, Republic of
9	Ulsan University Hospital	Ulsan		Korea, Republic of

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Yoon-Koo Kang, M.D., Ph.D., Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT00278863
• Other Study ID Numbers: AMC-ONCGI-0415
• First Posted: Jan 19, 2006
• Last Update Posted: Feb 25, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Yoon-Koo Kang, Professor, Asan Medical Center: Stomach cancer; Palliative chemotherapy; Capecitabine; S-1
• Additional relevant MeSH terms: Stomach Neoplasms; Capecitabine

Study Results

Participant Flow

Arm/Group Title	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
Arm/Group Description	S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.	Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Period Title: Overall Study
STARTED	49	47
COMPLETED	44	45
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	S-1 for 2 Weeks on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off	Total
Arm/Group Description	S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.	Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.	Total of all reporting groups
Overall Participants	45	46	91
Age, Customized (years) [Median (Full Range) ]
Age_median	71	71	71
Sex: Female, Male (Count of Participants)
Female	8 17.8%	16 34.8%	24 26.4%
Male	37 82.2%	30 65.2%	67 73.6%
Region of Enrollment (participants) [Number]
Korea, Republic of	45 100%	46 100%	91 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
Arm/Group Description	S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.	Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Measure Participants	45	44
Number (95% Confidence Interval) [percentage of participants]	28.9 64.2%	26.1 56.7%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	S-1 for 2 Week on/1 Week Off	Capecitabine 2 Weeks on/1 Week Off
Arm/Group Description	S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.	Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Measure Participants	42	44
Number [participants]	42 93.3%	44 95.7%

Adverse Events

Time Frame	Up to 2 years
Arm/Group Title	S-1 for 2 Week on/1 Week Off		Capecitabine 2 Weeks on/1 Week Off
Arm/Group Description	S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.		Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
All Cause Mortality
	S-1 for 2 Week on/1 Week Off		Capecitabine 2 Weeks on/1 Week Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	S-1 for 2 Week on/1 Week Off		Capecitabine 2 Weeks on/1 Week Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	S-1 for 2 Week on/1 Week Off		Capecitabine 2 Weeks on/1 Week Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/42 (100%)		44/44 (100%)
Blood and lymphatic system disorders
Anemia	37/42 (88.1%)		39/44 (88.6%)
Leukopenia	14/42 (33.3%)		10/44 (22.7%)
Neutropenia	10/42 (23.8%)		13/44 (29.5%)
Thrombocytopenia	12/42 (28.6%)		12/44 (27.3%)
Gastrointestinal disorders
Anorexia	31/42 (73.8%)		38/44 (86.4%)
Nausea	23/42 (54.8%)		22/44 (50%)
Vomiting	10/42 (23.8%)		10/44 (22.7%)
Abdominal pain	20/42 (47.6%)		19/44 (43.2%)
Stomatitis	9/42 (21.4%)		24/44 (54.5%)
Diarrhea	13/42 (31%)		16/44 (36.4%)
General disorders
Asthenia	34/42 (81%)		34/44 (77.3%)
Hepatobiliary disorders
Hyperbilirubinemia	13/42 (31%)		1/44 (2.3%)
Skin and subcutaneous tissue disorders
Hand-foot syndrome	7/42 (16.7%)		26/44 (59.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.