Status:
UNKNOWN
XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
Lead Sponsor:
Epidemiological and Clinical Research Information Network
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.
Detailed Description
XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment ...
Eligibility Criteria
Inclusion
- Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
- Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
- No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
- ECOG Performance Status of 0 to 2
- Life expectancy of at least 3 months after registration
- Written informed consent
- Age of 20 to 74 years with either gender
- Adequate Major organ functions within 14 days before registration
Exclusion
- Positive HER2 status
- Previous history of fluoropyrimidines therapy within 6 months prior to registration
- Previous treatment with platinum agents
- Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
- Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
- More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
- Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
- Active hepatitis
- Heart disease that is serious or requires hospitalization, or history of such disease within past year
- Having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
- Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
- Chronic diarrhea (watery stool or ≥4 times/day)
- Active gastrointestinal bleeding
- Body cavity fluids requiring drainage or other treatment
- Clinical suspicion or previous history of metastasis to brain or meninges
- Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
- Unwillingness to practice contraception
- Poor oral intake
- Psychiatric disorders which are being or may need to be treated with psychotropics
- Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01406249
Start Date
August 1 2011
End Date
December 1 2017
Last Update
July 27 2017
Active Locations (1)
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1
Epidemiological and Clinical Research Information Network
Kyoto, Japan, 606-8392