Clinical trial NCT01406249: XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: unresectable gastric cancer
recurrent gastric cancer
StageIV gastric cancer
adenocarcinoma of the stomach
XP
SP
Lead sponsor: Epidemiological and Clinical Research Information Network
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of Advanced Gastric Cancer.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival rate
timeFrame: at 24weeks from patient enrollment
Secondary outcomes:
measure: Time-to treatment failure
timeFrame: 3year
measure: Response rate
timeFrame: 3 year
measure: Overall survival
timeFrame: 3 year
measure: Safety
timeFrame: 3 year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Epidemiological and Clinical Research Information Network
Study officials:
affiliation: Shonan Kamakura Hospital
name: Akira Tsuburaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.