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
|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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||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 May 26, 2016
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action