XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Epidemiological and Clinical Research Information Network
First received: July 28, 2011
Last updated: February 2, 2016
Last verified: February 2016
The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)
Primary Outcome Measures:
- Progression-free survival rate [ Time Frame: at 24weeks from patient enrollment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time-to treatment failure [ Time Frame: 3year ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
Active Comparator: S-1,Cisplatin
S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle.
Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.
Experimental: Capecitabine, Cisplatin
Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.
Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.
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 of Advanced Gastric Cancer.
|Ages Eligible for Study:
||20 Years to 74 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01406249
|Epidemiological and Clinical Research Information Network
|Kyoto, Japan, 606-8392 |
Epidemiological and Clinical Research Information Network
||Shonan Kamakura Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Epidemiological and Clinical Research Information Network
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 28, 2011
||February 2, 2016
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by Epidemiological and Clinical Research Information Network:
unresectable gastric cancer
recurrent gastric cancer
StageIV gastric cancer
adenocarcinoma of the stomach
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 25, 2016
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action