Trial Outcomes & Findings for Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial (NCT NCT00278863)

Last Updated: 2014-02-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2014-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	S-1 for 2 Week on/1 Week Off 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 2 Weeks on/1 Week Off Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Overall Study STARTED	49	47
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	S-1 for 2 Weeks on/1 Week Off n=45 Participants 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 2 Weeks on/1 Week Off n=46 Participants Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.	Total n=91 Participants Total of all reporting groups
Age, Customized Age_median	71 years n=5 Participants	71 years n=7 Participants	71 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	30 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment Korea, Republic of	45 participants n=5 Participants	46 participants n=7 Participants	91 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	S-1 for 2 Week on/1 Week Off n=45 Participants 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 2 Weeks on/1 Week Off n=44 Participants Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Response Rate	28.9 percentage of participants Interval 15.6 to 42.1	26.1 percentage of participants Interval 13.4 to 38.8

SECONDARY outcome

Timeframe: Up to 2 years

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

Outcome measures

Outcome measures
Measure	S-1 for 2 Week on/1 Week Off n=42 Participants 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 2 Weeks on/1 Week Off n=44 Participants Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Number of Patients With Adverse Events	42 participants	44 participants

Adverse Events

S-1 for 2 Week on/1 Week Off

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Capecitabine 2 Weeks on/1 Week Off

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	S-1 for 2 Week on/1 Week Off n=42 participants at risk 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 2 Weeks on/1 Week Off n=44 participants at risk Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle.
Blood and lymphatic system disorders Anemia	88.1% 37/42 • Up to 2 years	88.6% 39/44 • Up to 2 years
Blood and lymphatic system disorders Leukopenia	33.3% 14/42 • Up to 2 years	22.7% 10/44 • Up to 2 years
Blood and lymphatic system disorders Neutropenia	23.8% 10/42 • Up to 2 years	29.5% 13/44 • Up to 2 years
Blood and lymphatic system disorders Thrombocytopenia	28.6% 12/42 • Up to 2 years	27.3% 12/44 • Up to 2 years
General disorders Asthenia	81.0% 34/42 • Up to 2 years	77.3% 34/44 • Up to 2 years
Gastrointestinal disorders Anorexia	73.8% 31/42 • Up to 2 years	86.4% 38/44 • Up to 2 years
Gastrointestinal disorders Nausea	54.8% 23/42 • Up to 2 years	50.0% 22/44 • Up to 2 years
Gastrointestinal disorders Vomiting	23.8% 10/42 • Up to 2 years	22.7% 10/44 • Up to 2 years
Gastrointestinal disorders Abdominal pain	47.6% 20/42 • Up to 2 years	43.2% 19/44 • Up to 2 years
Gastrointestinal disorders Stomatitis	21.4% 9/42 • Up to 2 years	54.5% 24/44 • Up to 2 years
Gastrointestinal disorders Diarrhea	31.0% 13/42 • Up to 2 years	36.4% 16/44 • Up to 2 years
Skin and subcutaneous tissue disorders Hand-foot syndrome	16.7% 7/42 • Up to 2 years	59.1% 26/44 • Up to 2 years
Hepatobiliary disorders Hyperbilirubinemia	31.0% 13/42 • Up to 2 years	2.3% 1/44 • Up to 2 years

Additional Information

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place