XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
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)
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Aug 2011
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 27, 2017
July 1, 2017
6.3 years
July 28, 2011
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival rate
at 24weeks from patient enrollment
Secondary Outcomes (4)
Time-to treatment failure
3year
Response rate
3 year
Overall survival
3 year
Safety
3 year
Study Arms (2)
S-1,Cisplatin
ACTIVE COMPARATORCapecitabine, Cisplatin
EXPERIMENTALInterventions
Drug: S-1: 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. Drug: Cisplatin: Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.
Drug: Capecitabine: 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. Drug: Cisplatin: Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Epidemiological and Clinical Research Information Network
Kyoto, 606-8392, Japan
Related Publications (1)
Tsuburaya A, Morita S, Kodera Y, Kobayashi M, Shitara K, Yamaguchi K, Yoshikawa T, Yoshida K, Yoshino S, Sakamoto J. A randomized phase II trial to elucidate the efficacy of capecitabine plus cisplatin (XP) and S-1 plus cisplatin (SP) as a first-line treatment for advanced gastric cancer: XP ascertainment vs. SP randomized PII trial (XParTS II). BMC Cancer. 2012 Jul 23;12:307. doi: 10.1186/1471-2407-12-307.
PMID: 22824079DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Akira Tsuburaya
Shonan Kamakura Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 1, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 27, 2017
Record last verified: 2017-07