Capecitabine vs. S-1 in Elderly AGC: Randomized Phase II Trial

This study has been completed.

First Received: January 17, 2006 Last Updated: November 28, 2007 History of Changes

Sponsored by:	Asan Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00278863

Purpose

A significant proportion of stomach cancer 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	Intervention	Phase
Gastric Cancer	Drug: S-1 Drug: Capecitabine	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: S 1 (Combination) Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Response rate

Secondary Outcome Measures:

Toxicities, Time to treatment failure, PFS, OS, QOL

Estimated Enrollment:	94
Study Start Date:	November 2004
Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically proven gastric or gastroesophageal junction adenocarcinoma
Metastatic or recurrent unresectable disease
Measurable lesions (according to RECIST)
Age: 65-85 years old
Performance status: ECOG 0-2
Adequate bone marrow function (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 UNL, AST/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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278863

Locations

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

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator:

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

Asan Medical Center

More Information

No publications provided

Study ID Numbers:	AMC-ONCGI-0415
Study First Received:	January 17, 2006
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00278863 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:

Stomach cancer
Palliative chemotherapy
Capecitabine
S-1

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer
Recurrence

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009