Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments sp, xp
Phase phase 2
Sponsor Epidemiological and Clinical Research Information Network
Start date August 2011
End date December 2016
Trial size 100 participants
Trial identifier NCT01406249, ECRIN-GC1107-XParTS II, UMIN000006045

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
sp
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.
(Experimental)
xp
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.

Primary Outcomes

Measure
Progression-free survival rate
time frame: at 24weeks from patient enrollment

Secondary Outcomes

Measure
Time-to treatment failure
time frame: 3year
Response rate
time frame: 3 year
Overall survival
time frame: 3 year
Safety
time frame: 3 year

Eligibility Criteria

Male or female participants from 20 years up to 74 years old.

Inclusion Criteria: 1. Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease 2. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1) 3. No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy 4. ECOG Performance Status of 0 to 2 5. Life expectancy of at least 3 months after registration 6. Written informed consent 7. Age of 20 to 74 years with either gender 8. Adequate Major organ functions within 14 days before registration Exclusion Criteria: 1. Positive HER2 status 2. Previous history of fluoropyrimidines therapy within 6 months prior to registration 3. Previous treatment with platinum agents 4. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents 5. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency 6. 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. 7. Obvious infection or inflammation (pyrexia ≥ 38.0˚C) 8. Active hepatitis 9. Heart disease that is serious or requires hospitalization, or history of such disease within past year 10. 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) 11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium 12. Chronic diarrhea (watery stool or ≥4 times/day) 13. Active gastrointestinal bleeding 14. Body cavity fluids requiring drainage or other treatment 15. Clinical suspicion or previous history of metastasis to brain or meninges 16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 17. Unwillingness to practice contraception 18. Poor oral intake 19. Psychiatric disorders which are being or may need to be treated with psychotropics 20. Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Additional Information

Official title 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)
Principal investigator Akira Tsuburaya
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 of Advanced Gastric Cancer.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Epidemiological and Clinical Research Information Network.